Merck discontinues arm of phase III trial evaluating vibostolimab + pembrolizumab in adjuvant high-risk melanoma

Merck acquires Modifi Biosciences

Modifi Biosciences Inc., a Yale University spinout company formed in 2021 that develops direct DNA-modification-enabled cancer therapeutics, has been acquired by Merck.

October 25, 2024

Vol.50 No.40

Drugs & Targets

EC approves Keytruda combinations for endometrial carcinoma indication, FIGO 2014 stage III-IVA locally advanced cervical cancer

The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.

October 25, 2024

Vol.50 No.40

Clinical Roundup

Keytruda meets primary endpoint as perioperative treatment regimen in resected, locally advanced HNSCC

The phase III KEYNOTE-689 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma met its primary endpoint of event-free survival.

October 11, 2024

Vol.50 No.38

Regulatory News

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted positive opinions recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, for two indications in gynecologic cancers.

September 27, 2024

Vol.50 No.36

Merck discontinues arm of phase III trial evaluating vibostolimab + pembrolizumab in adjuvant high-risk melanoma

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Merck acquires Modifi Biosciences

EC approves Keytruda combinations for endometrial carcinoma indication, FIGO 2014 stage III-IVA locally advanced cervical cancer

Keytruda meets primary endpoint as perioperative treatment regimen in resected, locally advanced HNSCC

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

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Merck discontinues arm of phase III trial evaluating vibostolimab + pembrolizumab in adjuvant high-risk melanoma

YOU MAY BE INTERESTED IN

Merck acquires Modifi Biosciences

EC approves Keytruda combinations for endometrial carcinoma indication, FIGO 2014 stage III-IVA locally advanced cervical cancer

Keytruda meets primary endpoint as perioperative treatment regimen in resected, locally advanced HNSCC

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitorsVote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications

EU CHMP gives positive opinion to Keytruda for two types of gynecologic cancers

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ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications