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Pharma Stock Roundup: AZN Gets Approvals for Imfinzi Expanded Use, MRK Inks New Deal
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This week, Merck (MRK - Free Report) announced a new collaboration with a private drugmaker. AstraZeneca (AZN - Free Report) gained approvals for the expanded use of its PD-L1 inhibitor Imfinzi in the United States and EU. Pfizer (PFE - Free Report) announced positive top-line data from a study evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo in immunocompromised adults.
Recap of the Week’s Most Important Stories
AstraZeneca Gets EU and U.S Approvals for Imfinzi’s Expanded Use: The European Commission granted approval to a combination of AstraZeneca’s PD-L1 inhibitor, Imfinzi and PARP inhibitor, Lynparza, for the treatment of certain patients with primary advanced or recurrent endometrial cancer. The approval is for Imfinzi plus chemotherapy followed by Imfinzi and Lynparza as a first-line treatment for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer. The regulatory body also approved Imfinzi plus chemotherapy followed by Imfinzi alone for mismatch repair deficient (dMMR) disease.
The approval for both regimens was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the phase III DUO-E study in the United States in June.
The FDA granted approval to Imfinzi for treating resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) based on data from the phase III AEGEAN study. In this regimen, patients who have no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. Regulatory applications are currently under review in the EU, China and several other countries for this setting based on the AEGEAN results.
Imfinzi is already approved for treating unresectable Stage III NSCLC based on data from the PACIFIC study in some countries, including in the United States.
The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking approval of Imfinzi for patients with limited-stage small cell lung cancer (LS-SCLC) in the United States. The sBLA was based on data from the ADRIATIC phase III study, which evaluated Imfinzi for treating patients with LS-SCLC who had not progressed following standard-of-care concurrent chemoradiotherapy. The FDA’s decision on the BLA is expected in the fourth quarter. Imfinzi was also recently granted Breakthrough Therapy Designation by the FDA for the same indication.
Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage SCLC, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.
Merck to Acquire B-Cell Depletion Therapy: Merck announced that it has entered into a definitive agreement to acquire global rights to CN201, a next-generation CD3xCD19 bispecific antibody, for the treatment of B-cell associated diseases, from a private biotech called Curon Biopharmaceutical.
In early-stage studies, CN201 has shown the potential to target and deplete circulating and tissue B cells, which can have potential applications in B-cell malignancies and autoimmune diseases. For the deal, Merck will make an upfront payment of $700 million in cash to Curon Biopharmaceutical, with the latter also being entitled to up to $600 million in milestone payments. CN201 is currently being evaluated in early-stage studies for relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory B-cell acute lymphocytic leukemia. The transaction is expected to be closed in the third quarter of 2024.
Positive Data from Pfizer’s RSV Jab Study in Immunocompromised Adults: Pfizer announced positive top-line data from a pivotal phase III MONeT study evaluating two doses of its RSV vaccine, Abrysvo, in immunocompromised adults. Adults with immunocompromised conditions like cancer, end-stage renal diseases or autoimmune disorders have an increased risk of developing RSV-associated lower respiratory tract disease (LRTD).
While the study evaluated two 120 µg doses of Abrysvo, data showed that a single 120 µg dose of Abrysvo generated a strong neutralizing response against both subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups in the study. Abrysvo is currently approved for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants via maternal immunization.
The NYSE ARCA Pharmaceutical Index rose 4.15% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: AZN Gets Approvals for Imfinzi Expanded Use, MRK Inks New Deal
This week, Merck (MRK - Free Report) announced a new collaboration with a private drugmaker. AstraZeneca (AZN - Free Report) gained approvals for the expanded use of its PD-L1 inhibitor Imfinzi in the United States and EU. Pfizer (PFE - Free Report) announced positive top-line data from a study evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo in immunocompromised adults.
Recap of the Week’s Most Important Stories
AstraZeneca Gets EU and U.S Approvals for Imfinzi’s Expanded Use: The European Commission granted approval to a combination of AstraZeneca’s PD-L1 inhibitor, Imfinzi and PARP inhibitor, Lynparza, for the treatment of certain patients with primary advanced or recurrent endometrial cancer. The approval is for Imfinzi plus chemotherapy followed by Imfinzi and Lynparza as a first-line treatment for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer. The regulatory body also approved Imfinzi plus chemotherapy followed by Imfinzi alone for mismatch repair deficient (dMMR) disease.
The approval for both regimens was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the phase III DUO-E study in the United States in June.
The FDA granted approval to Imfinzi for treating resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) based on data from the phase III AEGEAN study. In this regimen, patients who have no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. Regulatory applications are currently under review in the EU, China and several other countries for this setting based on the AEGEAN results.
Imfinzi is already approved for treating unresectable Stage III NSCLC based on data from the PACIFIC study in some countries, including in the United States.
The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking approval of Imfinzi for patients with limited-stage small cell lung cancer (LS-SCLC) in the United States. The sBLA was based on data from the ADRIATIC phase III study, which evaluated Imfinzi for treating patients with LS-SCLC who had not progressed following standard-of-care concurrent chemoradiotherapy. The FDA’s decision on the BLA is expected in the fourth quarter. Imfinzi was also recently granted Breakthrough Therapy Designation by the FDA for the same indication.
Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage SCLC, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.
Merck to Acquire B-Cell Depletion Therapy: Merck announced that it has entered into a definitive agreement to acquire global rights to CN201, a next-generation CD3xCD19 bispecific antibody, for the treatment of B-cell associated diseases, from a private biotech called Curon Biopharmaceutical.
In early-stage studies, CN201 has shown the potential to target and deplete circulating and tissue B cells, which can have potential applications in B-cell malignancies and autoimmune diseases. For the deal, Merck will make an upfront payment of $700 million in cash to Curon Biopharmaceutical, with the latter also being entitled to up to $600 million in milestone payments. CN201 is currently being evaluated in early-stage studies for relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory B-cell acute lymphocytic leukemia. The transaction is expected to be closed in the third quarter of 2024.
Positive Data from Pfizer’s RSV Jab Study in Immunocompromised Adults: Pfizer announced positive top-line data from a pivotal phase III MONeT study evaluating two doses of its RSV vaccine, Abrysvo, in immunocompromised adults. Adults with immunocompromised conditions like cancer, end-stage renal diseases or autoimmune disorders have an increased risk of developing RSV-associated lower respiratory tract disease (LRTD).
While the study evaluated two 120 µg doses of Abrysvo, data showed that a single 120 µg dose of Abrysvo generated a strong neutralizing response against both subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups in the study. Abrysvo is currently approved for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants via maternal immunization.
The NYSE ARCA Pharmaceutical Index rose 4.15% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, Lilly rose the most (10.2%), while J&J declined the most (0.7%).
In the past six months, while AstraZeneca rose the most (32.1%), Merck declined the most (11.3%).
(See the last pharma stock roundup here: LLY, NVO, BAYRY Q2 Earnings, MRK’s New Deal & Other Updates)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Pfizer, AstraZeneca and Merck have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.