The FDA granted approval to Lilly’s (LLY - Free Report) RET inhibitor Retevmo (elpercatinib) for RET-altered lung and thyroid cancers and AstraZeneca (AZN - Free Report) /Merck’s (MRK - Free Report) Lynparza for an expanded ovarian cancer patient population. Meanwhile, the regulatory agency refused to review Bristol-Myers (BMY - Free Report) and bluebird bio’s regulatory application for a multiple myeloma candidate while granting priority review to Sanofi’s (SNY - Free Report) filing for a rare blood disorder candidate.
Recap of the Week’s Most Important Stories:
FDA Approves Lilly’s RET Inhibitor Selpercatinib: The FDA granted accelerated approval to Lilly’s oral RET inhibitor selpercatinib for RET-altered lung and thyroid cancers. The drug (40 mg & 80 mg capsules) will be marketed by the trade name of Retevmo for treating metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC and advanced or metastatic RET fusion-positive thyroid cancer
The approval was based on data from the LIBRETTO-001 phase I/II study. Selpercatinib was added to Lilly’s portfolio with the February 2019 acquisition of Loxo Oncology.Meanwhile, selpercatinib is also being evaluated in late-stage studies for previously untreated patients with RET fusion-positive non-small cell lung cancer.
FDA’s Refuses to Review Bristol-Myers/ bluebird’s BLA for Ide-Cel: The FDA issued a refusal to file letter to Bristol-Myers and partner bluebird’s biologics license application (BLA) for their BCMA targeting CAR-T cell therapy candidate, idecabtagene vicleucel. The BLA, filed in March this year, sought approval for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma. The FDA has not requested for any additional data but has highlighted concerns about the manufacturing portion of the BLA. The companies expect to re-file the BLA by end of July. Idecabtagene vicleucel was added to Bristol-Myers’ pipeline with the 2019 buyout of Celgene.
Bristol-Myers announced data from the phase III CheckMate -9LA study evaluating Opdivo plus Yervoy plus limited chemotherapy versus chemotherapy alone for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) for the Opdivo+Yervoy+chemo arm compared to the chemotherapy arm.
FDA Approves AstraZeneca & Merck’s Lynparza for New Use: The FDA also granted approval to AstraZeneca & Merck’s Lynparza for a broader ovarian cancer population. Lynparza in combination with Roche’s Avastin has been approved as a maintenance treatment for first-line advanced ovarian cancer in women who have an HRD-positive tumor. The approval was based on data from the phase III PAOLA-1 study.
Lynparza, presently approved in three tumor types, ovarian, breast and pancreatic, is being evaluated as a monotherapy and in combination across multiple tumor types.
Meanwhile, the FDA granted Breakthrough Therapy Designation (BTD) to Enhertu for HER2-positive metastatic gastric cancer. The BTD was based on data from the registration phase II DESTINY-Gastric01 study.
FDA Grants Priority Review to Sanofi Sutimlimab: The FDA granted priority review to Sanofi’s regulatory application for its investigational monoclonal antibody sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD), a serious, chronic, rare blood disorder. With the FDA granting priority review to the BLA, a decision is expected on Nov 13. If approved by the FDA, sutimlimabwould become the first and only approved treatment for CAD patients.
Meanwhile, Sanofi’s second phase III study, evaluating its anti-CD38 monoclonal antibody, isatuximab, in patients with relapsed multiple myeloma, met the primary endpoint. The data from an interim analysis of the phase III IKEMA study showed that Sarclisa (isatuximab) added to carfilzomib and dexamethasone significantly reduced the risk of disease progression or death compared to carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. Sarclisa was approved in March by the FDA in combination with standard-of-care medicines, pomalidomide and dexamethasone (pom-dex) for the treatment of patients with relapsed/refractory multiple myeloma.
Merck Releases Cancer Data for ASCO: Merck announced data from several studies, which will be presented in an oral abstract session of the virtual scientific program of the annual meeting of the American Society of Clinical Oncology (ASCO). ASCO is scheduled to be held at the end of this month.
Data from a phase II study on Merck’s novel HIF-2α inhibitor, MK-6482, showed an objective response rate of nearly 30% in patients with von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (RCL). VHL is a rare hereditary condition affecting multiple organs, thus putting patients at risk for several cancers like RCL
Merck also presented data from a phase III (KEYNOTE-204) head-to-head study comparing its blockbuster PD-1 inhibitor Keytruda to brentuximab vedotin (BV), a current standard of care for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The data showed that Keytruda monotherapy significantly reduced the risk of disease progression or death by 35% and showed a median PFS of 13.2 months compared with 8.3 months for BV.
Meanwhile, data from a pivotal phase II study evaluating Keytruda plus chemotherapy compared to chemotherapy alone as first-line treatment in patients with metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10) showed that Keytruda plus chemotherapy reduced the risk of disease progression or death by 35% versus chemotherapy alone.
Several other drugmakers also released data from different cancer studies. The data will be presented during the virtual scientific program of the 2020 ASCO meeting.
AbbVie-Allergan Merger Closes: AbbVie (ABBV - Free Report) closed its pending acquisition of Allergan following receipt of all necessary regulatory approvals from government authorities and approval by the Irish High Court. The companies had announced the cash-and-stock deal worth nearly $63 billion in June last year. Last week, the U.S. Federal Trade Commission (FTC) cleared the merger. To close the merger, Allergan divested its mid-stage immunology candidate brazikumab and marketed medicine, Zenpep to AstraZeneca and Nestle, respectively. The acquisition of Allergan should diversify AbbVie’s revenue base to markets/categories outside AbbVie’s present drug portfolio and accelerate its non-Humira business.
The NYSE ARCA Pharmaceutical Index rose 1.6% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last five trading sessions.
Last week, AbbVie rose the most (6.7%) while Novartis declined the most (0.8%).
In the past six months, Lilly has risen the most (38.9%) while Novartis declined the most (7.0%).
(See the last pharma stock roundup here: Q1 Earnings of BMY, NVO, Coronavirus Update from PFE, RHHBY)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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