BRISTOL MYERS SQUIBB

10-year follow-up data from Bristol Myers Squibb's CheckMate-067 trial showed 43% of melanoma patients alive after receiving Opdivo and Yervoy combo, with median overall survival of 71.9 months. BMS also ended collaboration with Immatics, returning development of IMA401 to the biotech.

At ESMO's annual meeting, Pfizer's ponsegromab showed promise in treating cancer cachexia, helping patients regain weight and improve symptoms. Johnson & Johnson's TAR-200, a chemotherapy-releasing device, demonstrated efficacy in bladder cancer, with 42% of patients showing no cancer evidence. BioNTech and Instil Bio presented early data on drugs targeting PD1 and VEGF, similar to Summit Therapeutics' successful trial. Long-term studies revealed Keytruda's superior survival rates over Yervoy in melanoma patients. Scorpion Therapeutics' STX-478 showed potential as a PI3Ka inhibitor with manageable side effects.

The CheckMate -067 trial showed 10-year survival improvements with Opdivo (nivolumab) plus Yervoy (ipilimumab) or Opdivo monotherapy vs. Yervoy monotherapy in advanced melanoma, with median OS of 71.9 months, 36.9 months, and 19.9 months, respectively. The combination therapy demonstrated a 58.3% objective response rate after 10 years, with no new safety signals.

The Renal Cell Carcinoma Clinical Trial Pipeline Market is projected to grow significantly from 2024 to 2031, driven by technological innovations, rising demand, and regulatory changes. The market is segmented by type and application, with key players including Amgen, AstraZeneca, and Pfizer. Clinical trials focus on novel therapies, drug combinations, and targeted treatments, aiming to improve outcomes for renal cell carcinoma patients.

Drugmakers like Bristol Myers Squibb, AstraZeneca, and Eli Lilly invest billions in radiopharmaceuticals, which deliver radiation directly to tumors. These drugs, in development for various cancers, attach radioactive material to targeting molecules, sparing healthy cells. Novartis' successes with Lutathera and Pluvicto have spurred interest, but manufacturing and logistics remain complex. The market potential ranges from $5 billion to tens of billions, depending on efficacy across cancer types.

A decade-long study finds that a combination of nivolumab and ipilimumab significantly extends survival for patients with advanced melanomas, with median survival now over six years. The study, published in the New England Journal of Medicine, shows no increase in adverse effects over 10 years, suggesting these immunotherapy drugs can transform metastatic melanoma into a manageable, long-term condition.

A proposed bill could undermine university-private sector technology transfer, stifling innovation and economic growth. The Medication Affordability and Patent Integrity Act would require redundant paperwork, burdening the USPTO and FDA, and potentially exposing sensitive information, endangering national security.

Pembrolizumab (Keytruda) showed sustained survival benefits over ipilimumab (Yervoy) in unresectable stage III or IV melanoma patients, with 10-year follow-up data from the KEYNOTE-006 study presented at the 2024 ESMO Congress. Pembrolizumab had a median overall survival (OS) of 32.7 months vs 15.9 months for ipilimumab, with 8- and 10-year OS rates of 36.9% and 34.0% vs 24.8% and 23.6%, respectively. The study also highlighted the safety profile and long-term efficacy of pembrolizumab, supporting its standard of care status in advanced melanoma.

FDA decision deadlines include Vanda's tradipitant for gastroparesis (Sept 18), Zevra's arimoclomol for Niemann-Pick disease type C (Sept 21), Heron's extended-release needle for Zynrelef (Sept 23), Merck's Keytruda for pleural mesothelioma (Sept 25), and Bristol Myers Squibb's KarXT for schizophrenia (Sept 26). Sanofi and Regeneron await FDA verdict on Dupixent for COPD (Sept 27).