Here are the latest stories being discussed in biopharma today:
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FDA Approves Moderna’s RSV Vaccine, Marking Its Second Commercial Product
Moderna has secured FDA approval for its RSV vaccine, mResvia, for adults over 60. This marks the biotech company’s first non-Covid-19 product approval. With this approval, Moderna joins the competitive respiratory syncytial virus market alongside GSK and Pfizer, and the market is projected to reach $10 billion in the coming years. CEO Stéphane Bancel highlighted the strength of their mRNA platform, noting that it’s the first mRNA vaccine approved for a disease other than COVID-19.
Summit Therapeutics Touts Rare Triumph Over Keytruda in Lung Cancer from a China-only Phase 3 Study
Summit Therapeutics announced that its experimental cancer drug outperformed Merck’s Keytruda in a Phase 3 study among non-small cell lung cancer patients in China. The announcement led to a substantial 272% increase in Summit’s market capitalization, bringing it to $7.7 billion. This marks the first instance of a cancer drug surpassing Keytruda in this category, a significant milestone just before the opening of the ASCO conference in Chicago.
#ASCO24: Gilead Presents More Data on Failed Trodelvy Lung Cancer Study
Gilead’s antibody-drug conjugate Trodelvy, already approved for certain breast and bladder cancers, failed to extend overall survival in second-line metastatic non-small cell lung cancer in a Phase 3 trial. The EVOKE-01 trial showed a 16% reduction in the risk of death compared to chemotherapy but did not reach statistical significance, with median overall survival of 11.1 months versus 9.8 months for chemotherapy.
#ASCO24: Novartis’ New CML Treatment Tops Older Drugs Including Gleevec in Phase 3 Trial
At the ASCO meeting, Novartis shared that its chronic myeloid leukemia drug Scemblix outperformed older therapies in a Phase 3 trial, including the company’s own Gleevec and treatments from Bristol Myers Squibb and Pfizer. In the nearly 400-patient study, Scemblix showed superior disease control, potentially expanding its use from third-line to first-line therapy in Philadephia chromosome-positive chronic myeloid leukemia.
Novartis Shares Updated Data for BTK Inhibitor; Astellas Resubmits BLA for Cancer Drug After CRL
Novartis presented one-year data for its BTK inhibitor remibrutinib, showing significant improvements in disease activity, itch severity, and hive severity in chronic spontaneous urticaria. Angelika Jahreis, head of immunology development, noted that about 50% of patients reported no itch after one year. Meanwhile, Astellas has resubmitted its BLA for zolbetuximab for certain gastric cancer patients after addressing issues raised in a previous Complete Response Letter.
Gilead’s Blockbuster ADC Trodelvy Fails Bladder Cancer Confirmatory Study
Gilead reported that its antibody-drug conjugate Trodelvy did not improve patient survival in a Phase 3 study involving bladder cancer patients. The trial saw more deaths from adverse events within the Trodelvy group compared to the chemotherapy control group, primarily due to infections from low white blood cell counts. Trodelvy has been labeled as a cornerstone of Gilead’s oncology portfolio, having generated $1.1 billion in sales last year.
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