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Results For "pembrolizumab"

29 News Found

Merck discontinues Phase 3 KeyVibe-010 trial of coformulation of Vibostolimab and Pembrolizumab
Diagnostic Center | May 14, 2024

Merck discontinues Phase 3 KeyVibe-010 trial of coformulation of Vibostolimab and Pembrolizumab

Data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria


EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


Merck’s pembrolizumab plus chemotherapy showed sustained survival benefit versus chemotherapy alone
Diagnostic Center | September 12, 2022

Merck’s pembrolizumab plus chemotherapy showed sustained survival benefit versus chemotherapy alone

In first-line metastatic NSCLC, KEYTRUDA-based regimens have now shown a five-year survival benefit in four trials


Merck’s pembrolizumab demonstrates improvement in distant metastasis
News | June 06, 2022

Merck’s pembrolizumab demonstrates improvement in distant metastasis

Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


Merck’s Keytruda reduced the risk of death by 38% for patients with RCC
Diagnostic Center | January 29, 2024

Merck’s Keytruda reduced the risk of death by 38% for patients with RCC

Keynote -564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC


FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric
Drug Approval | November 17, 2023

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone


Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer
News | October 26, 2023

Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer

In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)