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Scientific Name: pembrolizumab

2022

Merck reports outcomes of several clinical trials for Keytruda® (pembrolizumab)

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.

FDA approves Roche’s Ventana® MMR RxDx Panel for the identification of patients eligible for Keytruda® (pembrolizumab)

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).

US | PDS0101 (novel T-cell HPV-specific immunotherapy) receives fast-track designation

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.

EU | EC approves additional indications for Merck’s Keytruda® (pembrolizumab)

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.

FDA accepts Merck sBLA for additional Keytruda® indication

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.

US | FDA lifts partial clinical hold on NEON-2 pembrolizumab trial

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.

First patients dosed in Biond Biologics trials for BND-22 (SAR444881) with pembrolizumab or cetuximab

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.

EU | Additional EU indications for Merck’s Keytruda®

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.

EC approves Keytruda® (pembrolizumab) for cervical cancer

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.

EU | Merck receives positive CHMP opinion for Keytruda® (pembrolizumab) in triple-negative breast cancer

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.

Study shows that levels of protein detected in head and neck tumours can be used to personalise patients’ medicine

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.

US | FDA approves Keytruda® (pembrolizumab) as a single agent for the treatment of patients with advanced endometrial carcinoma

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.

Merck announced results from Ph III trials of Keytruda® (pembrolizumab) in patients with Stage IB-IIIA non-small cell lung cancer

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.

Merck to discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer

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.

Merck publishes interim results from Ph III trials of Keytruda® (pembrolizumab) in melanoma

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.

EU | EC approves Keytruda® (pembrolizumab) for the treatment of renal cell carcinoma

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.

US | Remdesivir replaces Humira® as the most expensive drug by total member spend in Vizient’s Winter 2022 Market Outlook

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.

MSD and Eisai announce the publication of results from Ph III Keytruda® in endometrial carcinoma

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

Xbrane Biopharma announces it is developing pembrolizumab and daratumumab biosimilars

December 13, 2021

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

EU | CHMP recommends approving Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for renal cell cancer and endometrial carcinoma

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.

US | FDA approves Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab for cervical cancer

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.

Merck releases new data on Keytruda® (pembrolizumab) in resected stage II melanoma

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.

New study indicates pembrolizumab in combination with cetuximab shows promise as treatment for head and neck squamous cell carcinoma

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.

AU | AU’s PBAC recommends listing Mvasi, Keytruda and Stelara

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.

US | FDA approves expanded label for Keytruda® (pembrolizumab)

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.

Merck releases new data on Keytruda® (pembrolizumab) in combination with Lenvima® (levatinib)

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.

AU | PBAC publishes March outcomes

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.

BR | PlantForm announces deal with Bio-Manguinhos/Fiocruz

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.

US | Vizient releases Pharmacy Market Outlook

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

EU | Merck receives positive opinion from CHMP for pembrolizumab

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.

NeuClone Pharmaceuticals discloses potential biosimilar pembrolizumab

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.

JP | Merck announces additional approvals for Keytruda®

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.

Results from Ph III trials of Keytruda® released

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.

US | FDA approves Keytruda®

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

Celltrion announces potential pembrolizumab biosimilar

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 August 15, 2022