Platinum

FDA approves Merck's Keytruda for malignant pleural mesothelioma in combination with chemotherapy, improving survival rates in a Phase 3 trial.

FDA approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. KEYNOTE-483 trial showed improved overall survival (17.3 months vs 16.1 months) and objective response rate (52% vs 29%) with pembrolizumab plus chemotherapy. Adverse reactions were consistent with known side effects. Review conducted under Project Orbis, with ongoing reviews at other regulatory agencies.

Daiichi Sankyo and MSD report Phase III HERTHENA-Lung02 trial of patritumab deruxtecan met primary endpoint of progression-free survival in EGFR-mutated NSCLC patients. The trial showed a significant PFS improvement for patritumab deruxtecan versus chemotherapy, with a safety profile consistent with previous studies.

FDA approves Merck’s Keytruda for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial results showing significant survival and progression-free survival benefits.

FDA approves pembrolizumab (Keytruda) plus pemetrexed and platinum chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. KEYNOTE-483 study showed improved overall survival (OS) and progression-free survival (PFS) with pembrolizumab plus chemotherapy compared to chemotherapy alone. The combination also increased the objective response rate and reduced the risk of disease progression or death. Safety data indicated higher rates of adverse effects in the pembrolizumab arm, with fatigue and nausea being the most common.

FDA approves Keytruda plus chemo for unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial showing improved overall survival.

Merck and Daiichi Sankyo's patritumab deruxtecan met primary endpoint in Phase III HERTHENA-Lung02 study for EGFR-mutated non-small cell lung cancer, showing significant improvement in progression-free survival. Safety profile consistent with prior studies, though two grade 5 interstitial lung disease deaths occurred. Full results to be presented at a medical meeting.

Patritumab deruxtecan showed significant PFS improvement in HERTHENA-Lung02 trial for EGFR-mutated NSCLC patients previously treated with EGFR TKI, compared to platinum plus pemetrexed chemotherapy.

KEYNOTE-A18, a Phase 3 trial, showed KEYTRUDA (pembrolizumab) plus concurrent chemoradiotherapy (CRT) improved overall survival (OS) in high-risk locally advanced cervical cancer patients, reducing the risk of death by 33% compared to CRT alone. The results were presented at the ESMO Congress 2024 and published in The Lancet.