AstraZeneca AZN began a clinical study on a monoclonal-antibody cocktail therapy for COVID-19. The European Commission approved Glaxo’s GSK Blenrep (belantamab mafodotin) for the treatment of relapsed/refractory multiple myeloma. Novartis’ NVS melanoma candidate failed while a leukemia candidate met the primary endpoint in a phase III study.
Recap of the Week’s Most Important Stories
Clinical Studies Begin on AstraZeneca’s Cocktail Antibody for COVID-19: AstraZeneca began dosing of first patients in a phase I study on AZD7442, a monoclonal-antibody cocktail therapy for the prevention and treatment of COVID-19. AZD7442 is a combination of two monoclonal antibodies, AZD8895 and AZD1061, which AstraZeneca licensed from Vanderbilt University in the United States in June 2020. AstraZeneca has secured funding support from the Defense Advanced Research Projects Agency, part of the U.S. Department of Defense and BARDA for the phase I study and for manufacturing AZD7442.
AstraZeneca also presented detailed data from a phase III DAPA-CKD study evaluating Farxiga in patients with chronic kidney disease with and without type-2 diabetes at the ESC Congress 2020. The data showed that Farxiga significantly reduced the composite measure of worsening of renal function or risk of death in the study by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion in patients with and without type-2 diabetes
Novartis’ Melanoma Candidate Fails in Phase III Study: Novartis’ phase III study evaluating its candidate, spartalizumab (PDR001) in combination with Tafinlar + Mekinist in advanced BRAF V600-mutated melanoma failed to meet the primary endpoint of investigator-assessed progression-free survival. Nevertheless, the spartalizumab development program continues investigating the immunotherapy across a range of tumor types in combination with other anti-cancer agents.
Meanwhile, Novartis’ investigational novel STAMP inhibitor asciminib (ABL001) met the primary endpoint in a phase III study (ASCEMBL) evaluating it in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors. In the primary analysis, treatment with asciminib led to significant superiority in major molecular response rate at 24 weeks versus Pfizer’s Bosulif (bosutinib), thereby meeting the study’s primary endpoint.
Glaxo’s Belantamab Mafodotin Gets Approval in EU: The European Commission granted a conditional marketing authorization to Glaxo’s anti-BCMA therapy, belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in patients who have been previously treated with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The new drug, to be marketed by the trade name of Blenrep, was approved by the FDA earlier this month.
Merck’s Keytruda Gets Approval for Expanded Label in Japan: Merck’s MRK Keytruda gained approval for two new indications in Japan. Firstly, its six-week 400 mg dosing option was approved in Japan for all adult indications, including monotherapy and combination therapy. The new dosing option, which will be delivered as an intravenous infusion over 30 minutes, provides greater flexibility than the currently approved dose of 200 mg infused every three weeks over 30 minutes. The six-week dosing regimen is already approved in United States and Europe. Secondly, the Japanese regulatory authorities also granted approval for patients with PD-L1-positive esophageal squamous cell carcinoma who have progressed after chemotherapy. Keytruda is now approved for 13 indications across seven tumor types plus MSI-H tumors in Japan.
AbbVie Seeks Approval of Rinvoq for Ankylosing Spondylitis: AbbVie ABBV filed an application seeking approval of its JAK inhibitor Rinvoq (upadacitinib) for a new indication, active ankylosing spondylitis. Rinvoq was approved last year for treating moderate-to-severe rheumatoid arthritis. The regulatory filing for the active ankylosing spondylitis indication were based on data from the phase II/III study, SELECT-AXIS 1.
The NYSE ARCA Pharmaceutical Index rose 0.4% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Merck recorded the highest increase (0.8%) while Pfizer PFE declined the most (2.5%).
In the past six months, AstraZeneca has risen the most (21.4%) while Novartis has declined the most (0.3%).
(See the last pharma stock roundup here: SNY, JNJ Acquisition Deals, FDA Approvals)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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