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Trodelvy

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Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review
business1 month ago

Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review

Merck and Gilead announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 trial evaluating Trodelvy in combination with Keytruda for previously untreated metastatic NSCLC with PD-L1 TPS ≥50% after the external Data Monitoring Committee reviewed the final PFS data and interim OS analysis. While progression-free survival improved numerically, it did not reach statistical significance, and the likelihood of a statistically significant overall survival result at the planned final analysis is low. Safety was consistent with the known profiles of both drugs. Regulators were informed, investigators and patients advised to discuss treatment with physicians, and there are no changes to ongoing Trodelvy or Merck studies. Data will be presented at a future medical meeting.

via Merck.com|
#business#gilead#keytruda
Gilead Updates on Phase 3 TROPiCS-04 Study Progress
health2 years ago

Gilead Updates on Phase 3 TROPiCS-04 Study Progress

Gilead Sciences announced that the Phase 3 TROPiCS-04 study of Trodelvy in metastatic urothelial cancer did not meet its primary endpoint of overall survival. While some numerical improvements were observed, there were higher deaths due to adverse events with Trodelvy. Gilead will further investigate and discuss the results with the FDA. Trodelvy remains approved for other indications, and Gilead continues to explore its use in various cancers.

via Gilead Sciences|
#clinical-trials#gilead-sciences#health
"Gilead's Stock Plummets on Disappointing Lung Cancer Drug Trial Results"
business-healthcare2 years ago

"Gilead's Stock Plummets on Disappointing Lung Cancer Drug Trial Results"

Gilead's stock dropped over 10% after disappointing results from a late-stage trial showed that its drug, Trodelvy, did not significantly extend the lives of patients with a certain type of lung cancer. Despite the drug already being approved for some types of breast and bladder cancers, the phase-three study aimed to expand its use. Gilead will discuss the results with regulators to determine if certain lung cancer patients may still benefit from the drug, which belongs to the sought-after class of antibody-drug conjugates. Analysts suggest that the trial results could impact investor confidence in Gilead's potential sales in oncology.

via CNBC|
#business-healthcare#gilead#lung-cancer
healthcare2 years ago

"Gilead's Stock Plummets on Disappointing Phase 3 Lung Cancer Study Results"

Gilead Sciences announced that its Phase 3 EVOKE-01 study evaluating Trodelvy did not meet its primary endpoint of overall survival in previously treated metastatic non-small cell lung cancer (NSCLC). Despite this, a numerical improvement in overall survival favoring Trodelvy was observed, particularly in patients non-responsive to last prior anti-PD-(L)1 therapy. Gilead plans to discuss the results with regulators and explore potential pathways to understand Trodelvy's role in these patients. The company remains confident in its broader lung cancer clinical development program and intends to present the data at an upcoming medical meeting. Trodelvy is the first approved Trop-2-directed antibody-drug conjugate for certain types of metastatic breast cancers and metastatic urothelial cancer, but its safety and efficacy for metastatic NSCLC have not been established.

via Gilead Sciences|
#cancer-treatment#clinical-trial#gilead-sciences
"Gilead's Trodelvy Disappoints in Lung Cancer Trial, Stock Tumbles"
healthcare2 years ago

"Gilead's Trodelvy Disappoints in Lung Cancer Trial, Stock Tumbles"

Gilead Sciences' antibody drug conjugate, Trodelvy, did not significantly extend the lives of patients with metastatic non-small cell lung cancer in a recent study, raising questions about the effectiveness of this type of treatment in oncology. The disappointing results from the Evoke-01 study have implications for investors and oncologists, as antibody drug conjugates are considered a promising area in cancer treatment, combining an antibody with chemotherapy to target cancer cells.

via STAT|
#antibody-drug-conjugates#gilead-sciences#healthcare