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Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: pembrolizumab

2024

March 11, 2024

On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based chemotherapy.  Keytruda® is the first immuno-oncology drug approved in Korea for the treatment of all types of HER2-positive and negative metastatic gastric cancer.

March 4, 2024

On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite instability-high (MSI-H).    These four IPRs are IPR2024-00622 (against US10,934,356), IPR2024-00623 (against US11,325,974), IPR2024-00624 (against US11,325,975), and IPR2024-00625 (against US11,339,219).  Each IPR is based on anticipation and obviousness.  The petitions have not yet been instituted by the USPTO.

In November 2022 Merck filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel in relation to the same four patents.   The trial has not yet been scheduled.

February 21, 2024

Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab).  The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy.  This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27. 

Each of Formycon, Xbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024.

February 12, 2024

On 12 February 2024, Merck announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or gastroesophageal junction adenocarcinoma with tumours expressing PD-L1 (Combined Positive Score [CPS] ≥ 1).  

In January 2024, Merck announced that the FDA approved KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy for Stage III-IVA cervical cancer. 

January 31, 2024

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with Merck’s Keytruda® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.  On 26 January 2024, the EMA approved a Type II variation for the same indication.

January 29, 2024

Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

January 12, 2024

Merck announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.

2023

December 15, 2023

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

This approval comes considerably earlier than expected.  Merck announced only in November 2023 that the FDA had accepted (for priority review) its new supplemental Biologics License Application (sBLA) seeking this approval.  At that time the FDA had set a target action date of 9 May 2024.

November 30, 2023

Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.  The FDA has set a target action date of 9 May 2024.

November 16, 2023

Merck announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.   

On 7 November 2023, the FDA revised the existing indication for Keytruda® for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ).

November 15, 2023

The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab).  Samsung appears to be ahead of several other companies in its pembrolizumab biosimilar clinical programme, noting that Samsung must commence its trial within a year of the approval.  Formycon, Xbrane and Celltrion previously announced that they have pembrolizumab biosimilars in development.  Formycon reported in its nine-month financial results for 2023 that its pembrolizumab clinical programme will commence in 2024Xbrane reported in its financial reports for Jan-Jun 2023 that its pembrolizumab biosimilar candidate, Xtrudane™, is in preclinical development.  Celltrion has not provided an update on the status of its development. 

November 7, 2023

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy.  The updated indication is restricted to patients whose tumors express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.  Both the original and updated indication were approved under accelerated approval regulations.

The same indication was approved in Europe in August 2023, similarly limited to adults whose tumors express PD-L1 ( [CPS]≥1).

November 1, 2023

Merck announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.  This brings the total number of US approved gastrointestinal-related indications for Keytruda® to six.

In October the FDA approved Keytruda® for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

October 16, 2023

Merck made two announcements regarding new indications approved for Keytruda® (pembrolizumab):

  • In the US the FDA granted approval for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. This brings the total number of NSCLC-related indications for Keytruda® in the US to six.
  • In Europe the European Commission (EC) granted approval for Keytruda® as a monotherapy for the adjuvant treatment of adults with SCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

October 13, 2023

Merck announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

This will be the second indication for Keytruda® for the first-line treatment of such cancers in EU, following approval of Keytruda® in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy in August 2023.

September 15, 2023

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

CHMP also adopted a positive opinion for three new biologics:

  • Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
  • Novartis’ Finlee® (dabrafenib) to treat glioma; andlanadelumab
  • Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).

The CHMP recommended indication extensions for the following biologics:

  • Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
  • Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
  • Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
  • Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
  • Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
  • Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.

September 14, 2023

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

August 29, 2023

Merck announced that the European Commission has approved a new indication for Keytruda® (pembrolizumab) – first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Scope [CPS]≥1), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy.

Merck stated that Keytruda® is the first immunotherapy approved in the EU for the first-line treatment of this patient population.  Keytruda is approved globally for the treatment of a large range of cancers.  In June 2022 the EC approved Keytruda® for expanded melanoma indications.

August 11, 2023

Zumutor Biologics announced that FDA has granted its Investigational New Drug (IND) application for ZM008 (IgG1 monoclonal antibody) to initiate a phase I clinical study for the treatment of multiple solid cancers. The FDA approved the use of a staggered parallel clinical design for the combination of ZM008 and pembrolizumab which could benefit a wider range of patients whose immune response could be boosted with ZM008.

July 21, 2023

Merck announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).

If approved, Keytruda® would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU.

June 8, 2023

Merck announced the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin chemotherapy for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

June 3, 2023

Merck announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy.   

Merck reported that its Phase 3 KEYNOTE-671 trial evaluating Keytruda® plus chemotherapy before surgery and continued as a single agent after surgery showed reduced risk of disease recurrence, progression or death by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC).  Merck previously announced that, based on these results, the U.S. Food and Drug Administration (FDA) accepted a new supplemental Biologics License Application (sBLA) for Keytruda® for the treatment of these patients in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment, with a target action date of October 16, 2023.  

Merck also reported that its Phase 3 KEYNOTE-483 trial evaluating Keytruda® plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma showed significantly improved overall survival chemotherapy alone.   

May 23, 2023

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending Merck’s Keytruda® (pembrolizumab) combined with Eisai’s Lenvima® (lenvatinib) as an option for treating advanced or recurrent endometrial cancer in adults whose cancer has progressed on or after platinum-based chemotherapy who cannot have curative surgery or radiotherapy, in the NHS in England and Wales.

In March 2023, NICE recommended the use of Keytruda® for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.

April 6, 2023

Merck and Moderna announced that their joint investigational personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda®, Merck’s anti-PD-1 therapy has been granted Priority Medicines (PRIME) scheme designation by the EMA for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.  The designation was based on data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial which will be presented at the American Association for Cancer Research (AACR) from April 14-19 2023.

In December 2022 we reported on the phase IIb KEYNOTE-942/mRNA-4157-P201 trial, and in October 2022 Merck announced that it had exercised its option to jointly develop and commercialise mRNA-4157/V940.

March 29, 2023

The UK’s National Institute for Heath Care and Excellence (NICE) has recommended the use of Merck’s Keytruda® (pembrolizumab) for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.  This is the first immunotherapy drug for an advanced form of the disease, and Clinical Trials Arena reported that this is the first new treatment regime in this condition in 14 years.

March 1, 2023

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

  • Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatitis and uncontrolled severe asthma in patients aged 12 years and older.
  • Merck’s pembrolizumab (Keytruda®) for the treatment of persistent, recurrent, or metastatic (Stage IVB) squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma of the cervix in patients whose tumours express PD-L1 combined positive score equal to or greater than 1. This is further to pre-existing listing for unresectable Stage III or Stage IV malignant melanoma, resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma, relapsed or refractory Hodgkin lymphoma, Stage IV (metastatic) non-small cell lung cancer, locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, relapsed or refractory primary mediastinal B-cell lymphoma, unresectable or metastatic deficient mismatch repair colorectal cancer and recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx.
  • Pfizer’s pneumococcal polysaccharide conjugate vaccine, for the prevention of pneumococcal disease in individuals with an at-risk condition (≥ 18 years), non-Indigenous adults aged ≥ 70 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years. This was the first submission of the vaccine for the proposed vaccination populations.
  • AbbVie’s risankizumab (Skyrizi®) (which was on the July 2022 PBAC meeting agenda but a decision was deferred to November 2022) to treat adults with severe Crohn’s disease, who have failed to achieve an adequate response, or are contraindicated, to prior systemic therapy, further to pre-existing listing for treatment for severe chronic plaque psoriasis

February 22, 2023

Merck (known as MSD outside of the United States and Canada) and Moderna announced a new investigational mRNA cancer vaccine mRNA-4157/V940 combined with Keytruda® (pembrolizumab) has been granted Breakthrough Therapy Designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. The designation will result in expedition of the FDA’s the  review of the combination treatment. According to the release, the companies will initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumor types (including non-small cell lung cancer). Merck and Moderna exercised the option to jointly develop the treatment in October 2022.

February 3, 2023

Merck announced that Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy met its primary endpoint of progression-free survival for the treatment of stage III-IV or recurrent endometrial carcinoma.  Reportedly, the safety profile of Keytruda was consistent with that observed previously, with no new safety signals identified.

2022

December 30, 2022

OncoC4 announced that the first patient has been dosed in Ph II trials of ONC-392 (nextgen target-preserving anti-CTLA-4 antibody) and Keytruda® (pembrolizumab) in patients with platinum-resistant ovarian cancer.  The study is sponsored by OncoC4 in collaboration with Merck and GOG Foundation Inc.

December 15, 2022

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).  Under the agreement, Doer Bio will conduct the clinical study in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.

December 3, 2022

Reuters reported that Merck hopes to patent subcutaneous formulations of Keytruda® (pembrolizumab).  Merck has several studies evaluating subcutaneous pembrolizumab planned or underway, according to a search of clinicaltrials.gov and a previous press release.  A subcutaneous formulation may be more convenient for patients and healthcare providers, and therefore has the potential to replace the current infusion regime in many settings.  Reuters reported that Merck CFO Caroline Litchfield stated that Merck believes such a formulation would be patentable, which could mean Merck’s patent protection for its blockbuster is extended for a considerable period of time.  The report states that Merck is anticipating biosimilar competition for the infusion product by 2028.

November 29, 2022

Merck has filed a complaint in the United States District Court (District of Maryland) against The Johns Hopkins University in relation to certain patents of the university relating to Keytruda® (pembrolizumab).  Based on the wording of the complaint, the dispute arose out of a contract between Merck and the university to design and conduct a clinical trial on administration regimes for Keytruda® in cancer patients with certain genetic biomarkers.  The complaint alleges that the university was issued four US patents in 2021 and 2022 that cite the joint study but that the university claimed the inventions arose prior to the study, and that it exclusively licensed the patents to others, demanding payment from Merck for use of Keytruda®.  Merck is seeking from the court a declaration that the university breached the contract for the clinical trial, damages for breach of contract and declarations that Merck’s manufacture, use, sale offer for sale and/importation of Keytruda® do not infringe any of the patents in question.

 

November 22, 2022

Merck announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck reported that the treatment showed significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS), and that significant and clinically meaningful improvement in progression-free survival (PFS) and overall response rate (ORR) were also observed.  Keytruda is already approved by the FDA and elsewhere for other gastric and GEJ tumours.

November 8, 2022

NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer.  NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).

October 28, 2022

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

  • Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
  • Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
  • Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
  • Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
  • Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

October 27, 2022

Merck announced its third quarter 2022 financial results on 27 October.  Worldwide sales for the quarter were $15.0 billion, an increase of 14% from third quarter 2021.  $5.4 billion of this was attributable to KEYTRUDA® (pembrolizumab), sales for which had grown 20% over third quarter 2021.

October 12, 2022

Merck announced that it has exercised its option to jointly develop and commercialise the personalised cancer vaccine mRNA-4157/V940 under the terms of the Collaboration and License Agreement originally signed by Merck and Moderna in 2016.  Moderna is conducting a Phase 2 clinical trial evaluating mRNA-4157/V940 in combination with Merck’s KEYTRUDA® as adjuvant treatment for patients with high-risk melanoma. Primary data are expected in Q4 2022.

September 27, 2022

Merck announced that Japan’s Ministry of Health has granted approval of Keytruda (pembrolizumab) for four new indications: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC); in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer; and as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection.  With these new approvals, Keytruda is now approved for 23 uses in 13 different types of cancer in Japan.

September 26, 2022

The Australian Department of Health and Aged Care announced that from 1 October 2022 Keytruda (pembrolizumab) will be included in the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of squamous cell carcinoma of the head and neck.   The Health Minister reported that without subsidy patients can pay more than AUD $135,000 per course of treatment, but with the PBS listing, this treatment will cost patients less than AUD $50 per prescription.   Keytruda is already PBS-listed for a range of cancers including malignant melanoma, Hodgkin’s lymphoma, non-small cell lung cancer (NSCLC), urothelial cancer, B-cell lymphoma and colorectal cancer.

September 19, 2022

Formycon disclosed that it is developing a biosimilar of Keytruda® (pembrolizumab), referred to as FYB206.  The project is at an advanced preclinical stage, with GMP manufacturing planned for the end of 2022.

September 13, 2022

Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), for the adjuvant treatment of adult and paediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.

September 10, 2022

Merck reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11 September, including:

  • in patients with metastatic nonsquamous NSCLC, data from KEYNOTE-189 demonstrating KEYTRUDA plus pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) had a five-year overall survival (OS) rate of 19.4% versus 11.3% for chemotherapy alone; and
  • in patients with metastatic squamous NSCLC, results from KEYNOTE-407 showing the five-year OS rate for KEYTRUDA plus carboplatin-paclitaxel or nab-paclitaxel was 18.4% versus 9.7% for chemotherapy alone.

Separately, Eisai reported that would be presenting data on several trials on the combination of lenvatinib and pembrolizumab at the conference, including a late-breaking oral presentation of detailed results from the LEAP (Lenvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial as a first-line treatment for patients with unresectable hepatocellular carcinoma, as well as two mini-oral presentations with updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma, and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma.

August 29, 2022

Merck announced that it will present data on several oncology medicines at the European Society for Medical Oncology (ESCO) Congress in Paris from 9-13 September, including relating to KEYTRUDA® (pembrolizumab) and PADVEV® (enfortumab vedotin).

August 15, 2022

Merck’s PD-1 receptor blocker Keytruda is approved in the US and Europe for the treatment of a range of tumours, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, oesophageal cancer, cervical cancer, renal cell carcinoma and triple negative breast cancer.  Merck has now reported updates on several clinical trials, in which treatment with Keytruda® did not reach its primary endpoints:

  • Phase 3 LEAP-002 trial investigating Keytruda® plus Eisai’s Lenvima® (lenvatinib), compared to Lenvima® monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). See the Merck update of 3 August here.
  • Phase 3 KEYNOTE-921 trial evaluating Keytruda® in combination with chemotherapy (docetaxel) compared to chemotherapy alone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). See the Merck update of 3 August here
  • Phase 3 KEYNOTE-412 trial evaluating Keytruda®with concurrent chemoradiation therapy (CRT) followed by Keytruda® as maintenance therapy for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). See the Merck update of 20 July here

In each trial clinical improvements were shown but they did not meet pre-specified statistical significance.  The safety profile from each trial was consistent with earlier studies.

August 11, 2022

Roche announced that the FDA has approved the use of its Ventana® MMR RxDx Panel as the first immunohistochemistry companion diagnostic test to aid in identifying patients who may be eligible for treatment with Keytruda®.  The panel is used to identify patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR).

August 11, 2022

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of systemic therapy.

July 2, 2022

PDS Biotechnology announced that the FDA has granted fast-track designation to PDS0101 (novel T-cell HPV-specific immunotherapy) in combination with Keytruda® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

June 24, 2022

Merck announced that the EC has approved Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, as well as expanding the indications for Keytruda® in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) in adolescent patients aged 12 years and older.

June 13, 2022

Merck announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.

May 24, 2022

Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced malignancies.   The partial clinical hold (now lifted) was implemented in March 2022 after a grade 5 serious adverse event leading to a patient’s death occurred.

May 23, 2022

Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exclusive world wide licence with Sanofi.

May 20, 2022

Merck announced that it has received a positive opinion from the CHMP for its  anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection.  CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).

Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.  Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.

April 29, 2022

Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1.

April 25, 2022

Merck announced that it received a positive CHMP opinion for its anti-PD-1 therapy Keytruda® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy in adjuvant treatment after surgery for adults with locally advanced, or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.

March 28, 2022

Medical Xpress reports on an Institute of Cancer Research, London, study showing that levels of the protein PD-L1 detected in head and neck tumours can be used to personalise medicine.  Depending on PD-L1 levels, patients should receive personalised medicine of either chemotherapy with or without cetuximab, pembrolizumab in combination with chemotherapy, or pembrolizumab alone.

March 21, 2022

Merck announced that the FDA has approved Keytruda® (pembrolizumab) (anti-PD-1 therapy) as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).  Keytruda® is also indicated in combination with Lenvima® (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR.

March 17, 2022

Merck announced results from Ph III trials of Keytruda® (pembrolizumab) in patients with Stage IB-IIIA non-small cell lung cancer, reporting that Keytruda® significantly improved disease-free survival.

March 15, 2022

Merck announced that it will discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer following the recommendation of an independent Data Monitoring Committee.  Merck said that interim analysis indicated that the combination treatment did not demonstrate a benefit in overall survival.

March 7, 2022

Merck published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma.  According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survival compared to placebo.

January 27, 2022

MSD announced that the EC has approved Keytruda® (pembrolizumab) for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

January 26, 2022

Vizient announced that remdesivir has replaced Humira® (adalimumab) as the most expensive drug by total member spend in its Winter 2022 Market Outlook.  Pembrolizumab, ustekinumab, ocrelizumab, denosumab, infliximab, nivolumab and tocilizumab also featured in the top 10 most expensive drugs by member spend.

January 20, 2022

MSD and Eisai announced the publication of results from Ph III studies of Keytruda® (pembrolizumab) in patients with advanced endometrial carcinoma.

2021

December 13, 2021

Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

October 15, 2021

Merck and Eisai announced that the CHMP has adopted positive opinions recommending the approval of the combination of Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for the first-line treatment of adults with advanced renal cell cancer and for the treatment of adults with advanced or recurrent endometrial carcinoma.

October 13, 2021

Merck announced that the FDA has approved Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

September 18, 2021

Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo in patients with resected high-risk stage II melanoma.

July 29, 2021

A new study published in Lancet Oncology reported that pembrolizumab in combination with cetuximab shows promise as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

July 6, 2021

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

July 6, 2021

Merck announced that the FDA has approved an expanded label for Keytruda® (pembrolizumab). Keytruda® is now also approved for the treatment of patients with recurrent of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

June 7, 2021

Merck released new data on Keytruda® (pembrolizumab) in combination with Lenvima® (levatinib) versus sunitinib in patients with advanced renal cancer. Merck said that the results reinforced the combination of pembrolizumab and levatinib as a potential new treatment option for renal cancer.

April 26, 2021

Australia’s PBAC published the outcomes of its March 2021 meeting. The recommendations include:

  • Mvasi® (Amgen’s biosimilar bevacizumab): the PBS listing has been changed to an unrestricted benefit to allow access to combination treatment with atezolizumab.
  • Beovu® (brolucizumab): Beovu® was recommended for subfoveal choroidal neovascularisation due to AMD.
  • Keytruda® (pembrolizumab): PBAC recommended Section 100 Authority Required listing for the treatment of metastatic colorectal cancer.

April 6, 2021

PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.

January 27, 2021

Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

2020

December 10, 2020

Merck receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

September 1, 2020

NeuClone Pharmaceuticals discloses it is working on a biosimilar referencing Keytruda® (pembrolizumab). The product is in the advanced stages of pre-clinical development and is being developed in partnership with the Serum Institute of India.

August 24, 2020

Merck announces Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

  • new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma;

  • and an additional dosage regimen of 400mg every six weeks as an IV infusion over 30 minutes, across all adult indications.

August 19, 2020

Merck announces the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and that the safety profile was consistent with that observed in previously reported studies.

June 29, 2020

Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

2018

February 14, 2018

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.

BioBlast® extract From February 14, 2018 to March 11, 2024