This week, Pfizer
PFE
announced its COVID-19 vaccine candidate is 90% effective at preventing the disease. The FDA gave Emergency Use Authorization (EMA) to Lilly’s
LLY
COVID-19 antibody drug, bamlanivimab
Recap of the Week’s Most Important Stories
Pfizer COVID-19 Vaccine is 90% Effective in Phase III:
Pfizer and its Germany-based partner, BioNTech announced first interim data from a phase III study on their mRNA-based coronavirus vaccine candidate, BNT162b2. The data showed that the candidate was more than
90% effective in preventing COVID-19
in participants without evidence of prior SARS-CoV-2 infection. The interim efficacy analysis was conducted by an external, independent Data Monitoring Committee (DMC). No serious safety concerns have been observed to date in the large global phase III study. Additional safety and efficacy data continue to be assessed and the companies will release additional data in the coming weeks.
Pfizer and BioNTech also signed an advance supply deal with the European Commission to supply
200 million doses of BNT162b2 to EU
member states. The agreement also includes an option to purchase additional 100 million doses.
Pfizer’s drug Xeljanz met the primary and key secondary endpoints in a phase III study evaluating it for the treatment of active ankylosing spondylitis (AS). The data from the study showed that at week 16, 56.4% of patients treated with Xeljanz achieved an ASAS20 response, the primary endpoint, versus 19.4% for placebo. Meanwhile, a significantly greater percentage of patients treated with Xeljanz showed ASAS40 response, a key secondary endpoint, compared to placebo. Pfizer’s application seeking approval for the AS indication is under review with the FDA with a decision expected in the second quarter of 2021. Xeljanz is presently approved for three indications, rheumatoid arthritis, active psoriatic arthritis and ulcerative colitis.
Lilly’s COVID-19 Antibody Candidate Gets FDA’s Emergency Tag
:
The FDA granted EUA to Lilly’s antibody drug, bamlanivimab (LY-CoV555) as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. Lilly’s BLA for bamlanivimab was based on data from the phase II BLAZE-1 study. The study also evaluated bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, a phase III study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities, is also ongoing.
AstraZeneca’s Cancer Drug Fails in COVID-19 Study:
A
phase II study CALAVI
evaluating AstraZeneca’s
AZN
leukemia/lymphoma medicine Calquence for treating patients hospitalized with respiratory symptoms of COVID-19, failed to meet the primary endpoint. The study failed to show that treatment with Calquence plus best supportive care (BSC) increased the proportion of patients who remained alive and free of respiratory failure.
The FDA approved blood thinner, Brilinta (in combination with aspirin) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA). The approval was based on data from the phase III THALES study. A similar application is also under review in China and in the EU.
Meanwhile, AstraZeneca’s leukemia drug, Calquence was approved in the European Union for chronic lymphocytic leukemia indication in both previously untreated and relapsed or refractory patients.
A phase III study (NAVIGATOR) evaluating AstraZeneca’s pipeline candidate, tezepelumab in a broad population of patients with severe asthma met the primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations.
Merck Ends Keytruda Lung Cancer Study for Futility:
Merck
MRK
stopped a phase II lung cancer study on Keytruda following the recommendation of an independent Data Monitoring Committee (DMC). The study evaluated Merck’s blockbuster PD-L1 inhibitor Keytruda in combination with Bristol-Myers’ Yervoy versus Keytruda monotherapy in certain patients with metastatic non-small cell lung cancer. The DMC determined the benefit/risk profile of the combination did not support continuing the study. The Keytruda + Yervoy combo did not show any incremental benefit in overall survival (OS) or progression-free survival (PFS), the study’s dual primary endpoints, compared with Keytruda.
Merck’s phase III study evaluating Keytruda plus Eisai’s Lenvima for first-line treatment of patients with advanced renal cell carcinoma met its primary endpoint of PFS and its key secondary endpoints of OS and objective response rate (ORR). Keytruda plus Lenvima demonstrated statistically significant improvement in PFS, OS and ORR versus Pfizer’s renal cancer drug Sutent.
J&J Seeks Label Expansion of Subcutaneous Darzalex:
J&J
JNJ
filed regulatory applications in the United States and EU seeking label expansion of subcutaneous formulation of Darzalex, known as Darzalex Faspro in the United States and Darzalex SC in the EU, for a new indication. The company is seeking approval of the product in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The regulatory applications were based on positive data from the phase III APOLLO study. The combination regimen is already approved as the IV formulation in the United States but not in the EU. The SC formulation will reduce administration time from hours to minutes compared with the IV formulation
The NYSE ARCA Pharmaceutical Index rose 1.2% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
While J&J recorded the maximum increase (6.1%), Roche
RHHBY
declined the most (3.6%).
In the past six months, while AbbVie
ABBV
recorded the maximum increase (8.5%), Lilly declined the most (10.9%).
(See the last pharma stock roundup here:
Q3 Earnings, Resumption of AZN/JNJ Coronavirus Vaccine Study
)
What’s Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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