This week, Pfizer PFE and its Germany-based partner BioNTech announced promising initial data from an early-stage clinical study on their coronavirus vaccine candidate. Meanwhile, the FDA granted approvals to Pfizer’s Bavencio and Merck’s MRK Keytruda for expanded indications/patient populations and Roche’s RHHBY new breast cancer injection, Phesgo. A few new drugs or line extensions of marketed drugs were approved in Europe and Japan.
Recap of the Week’s Most Important Stories:
Pfizer’s Promising Initial Data From Coronavirus Vaccine Study: Pfizer and BioNTech announced early positive data from the phase I/II U.S. clinical study on the most advanced (BNT162b1) of their four experimental mRNA-based vaccines, being evaluated under BioNTech’s BNT162 program, to prevent COVID-19. The preliminary data showed that BNT162b1, targeting the RBD of SARS-CoV-2 spike protein, can produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera, which means the serum of patients who have recovered from COVID-19. Moreover, the candidate could achieve this benefit at relatively low dose levels. Once, further clinical data on the four vaccine candidates is available, the companies will select the lead candidate and dose level for a larger, global phase IIb/III safety and efficacy study that may begin in July. Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021.
The FDA granted approval to Pfizer’s PD-L1 inhibitor Bavencio as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC), a form of bladder cancer. The approval is for patients whose disease has not progressed with first-line platinum-containing chemotherapy. Bavencio is already approved for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy. The supplemental biologics license application (sBLA) seeking approval for the expanded indication was based on interim data from the phase III JAVELIN Bladder 100 study.
FDA Approves Roche’s Phesgo Injection for Breast Cancer: TheFDA granted approval to Roche’s Phesgo, which combines its two monoclonal antibodies, Perjeta and Herceptin with hyaluronidase, for the treatment of HER2-positive breast cancer. Phesgo can be administered by a single subcutaneous injection and thus offers faster administration of Perjeta and Herceptin in just minutes, compared to hours with the standard intravenous administration of the two medicines.
FDA Approves Merck’s Keytruda for Expanded Use in Colorectal Cancer: The FDA also granted approval to Merck’s Keytruda for first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer. Until now, Keytruda was approved to treat MSI-H or dMMR colorectal cancer in patients whose cancer has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The latest approval came less than a month following filing of the supplemental biologics license application (sBLA). The sBLA was based on data from the phase III KEYNOTE-177 study.
Sanofi’s Coronavirus Study on Kevzara Fails: Sanofi SNY and partner Regeneron’s phase III study testing their drug Kevzara in critical COVID-19 patients failed to meet its primary and key secondary endpoints. The study was evaluating Kevzara (400 mg) in COVID-19 patients requiring mechanical ventilation when Kevzara was added to best supportive care compared to best supportive care alone. In April, the study was amended to enroll only “critical” patients and discontinue the “severe” group on the recommendation of the Independent Data Monitoring Committee.
Based on the latest data, the Sanofi-led U.S. based study has been stopped. However, a Sanofi-led outside U.S study in hospitalized patients with severe and critical COVID-19 using a different dosing regimen continues and so does the Regeneron-led U.S. study.
J&J to Discontinue Study on Stelara in Lupus: J&J JNJ announced its decision to discontinue the phase III study of its blockbuster medicine, Stelara in a new indication– systemic lupus erythematosus (SLE) based on data from an interim analysis of the study. J&J’s decision to discontinue the LOTUS study was due to lack of efficacy in the disease. Stelara is approved to treat active ulcerative colitis, psoriatic arthritis, moderate-to-severe Crohn's disease and plaque psoriasis.
EU Approvals for Several Drugs: The European Commission granted approval to Bristol-Myers BMY and partner Acceleron Pharma’s Reblozyl for the treatment of transfusion-dependent anemia associated with myelodysplastic syndromes (MDS) or beta thalassemia in adult patients. The approval was based on positive data from the phase III MEDALIST and BELIEVE studies, which evaluated the ability of Reblozyl to effectively address anemia associated withMDS and beta thalassemia, respectively.
The European Commission also granted approval to J&J’s two-dose Ebola vaccine regimen for the prevention of Ebola virus caused by Zaire strain. The Ebola vaccine has been developed using Janssen’s AdVac technology, the same technology used to develop its COVID-19 vaccine candidate. The vaccine is not yet approved in the United States.
Meanwhile, Pfizer’s Daurismo (glasdegib), a once-daily oral medicine was also approved in Europe for use in combination with low-dose cytarabine (LDAC) — a kind of chemotherapy treatment — for newly-diagnosed acute myeloid leukemia (AML) in patients who cannot take intensive chemotherapy. Daurismo is already approved in the United States.
Several Drug Approvals in Japan: The Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval to a few drugs this week. This included Novartis’ MET inhibitor Tabrecta, which it in-licensed from Incyte, for advanced non-small cell lung cancer with METex14. Tabrecta was approved by the FDA earlier this year. The MHLW also granted approval to Novo Nordisk’s type-II diabetes medicine Rybelsus, which is the oral formulation of its GLP-1 receptor agonist semaglutide. Rybelsus is already approved in the United States and the EU. Glaxo’s GSK daprodustat was also approved in Japan for anemia associated with chronic renal disease. The drug, to be called Duvroq, is not yet approved as a treatment for anemia due to CKD or any other indication in any other country than Japan.
The NYSE ARCA Pharmaceutical Index rose 1.1% in the last five trading sessions.
Here is how the nine major stocks performed in the last five trading sessions.
Last week, while Pfizer recorded the highest increase (6.8%), Novartis declined the most (2.3%).
In the past six months, Lilly has risen the most (23.9%) while Merck declined the most (14.1%).
(See the last pharma stock roundup here: FDA Approvals to MRK, LLY, NVS and GSK’s Drugs)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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