BioBlast® w/e 12 August 2022: Mylan Eylea® IPR, Daiichi Sankyo trastuzumab deruxtecan, Alvotech Icelandic listing move, Opthea funding for OPT-302, Merck Keytruda® clinical trials, Qila denosumab study

by , | Aug 15, 2022

Significant biosimilar activities this week include:

27 Jul 22 | CN | Ph III trial shows Qila’s denosumab biosimilar improves bone mineral density

It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed beneficial effects in post-menopausal Chinese women with osteoporosis and high fracture risk.  After twelve months, subjects who received QL1206 showed significantly improved bone mineral density in the lumbar spine, total hip, femoral neck and trochanter compared to placebo.

10 Aug 22 | US | PTAB hears Mylan’s IPR challenge to Regeneron’s Eylea® patents

The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022.  The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and analysts have reported that (at least) the ‘338 patent is likely to be invalidated, based on comments made by the PTAB during the proceedings.

11 Aug 22 | FDA approves Roche’s Ventana® MMR RxDx Panel for the identification of patients eligible for Keytruda® (pembrolizumab)

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).

11 Aug 22 | US | FDA approves Enhertu® (trastuzumab deruxtecan) for lung cancer

Daiichi Sankyo and AstraZeneca announced that the FDA has offered accelerated approval to Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations.  Continued approval for this accelerated indication may be contingent upon verification in a confirmatory trial.

12 Aug 22 | Alvotech Board approves move to Main Market in Iceland

Alvotech announced that its Board of Directors has approved to move its share listing from the First North Growth Market to the Nasdaq Main Market in Iceland.

Alvotech became the first dual US-Icelandic listed company on 23 June 2022.

14 Aug 22 | Australia’s Opthea secures Launch Tx funding for OPT-302 in wet AMD

Opthea announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics to finance and advance the ongoing Ph III clinical trials and pre-commercialisation activities of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) for wet age-related macular degeneration (wet AMD).  Under the agreement, the funds will commit US$120 million in three instalments at fixed time points, with an option to commit an additional US$50 million.  In exchange, Opthea will make a milestone payment after regulatory approval in a major market, followed by six annual fixed payments and variable success payments of 7% of net sales, with cumulative payments capped at four times the amount funded to Opthea.

August 22 | Merck reports outcomes of several clinical trials for Keytruda® (pembrolizumab)

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.

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