Merck...announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers...KEYTRUDA in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1.

US-based pharma major MSD (tradename of Merck & Co., Inc) announced that the Drugs Controller General of India (DCGI) has approved its anti cancer drug Keytruda (pembrolizumab), for additional indications of cervical cancer and esophageal cancer. The company said that the anti-programmed death receptor-1 (PD-1), has received approval for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS =1, and for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS = 10.

MSD’s Keytruda (ingredient: pembrolizumab) became a new treatment option for metastatic esophageal or gastroesophageal junction (GEJ) carcinomas that had no first-line therapy for decades...The MFDS said Keytruda could be used in combo with chemotherapy (platinum and fluoropyridine) in the first-line treatment of patients whose PD-L1 expression is positive (CPS≥10) with unresectable, locally advanced, or metastatic esophageal or HER2 minus GEJ carcinoma.

Merck...today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy...for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10)...KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival.

First-line therapy with pembrolizumab and CT is recommended for HER2-negative patients with esophageal or GEJ AC and PD-L1 CPS ≥ 10.

Pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy is recommended, within its marketing authorisation, as an option for untreated locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of 10 or more.

Gastroesophageal Junction Adenocarcinoma: Principles of systemic therapy...Preferred regimens…HER2 overexpression negative…Fluoropyrimidine (fluorouracil or capecitabine) and oxaliplatin, and pembrolizumab (PDL1 CPS ≥ 10)...Fluoropyrimidine (fluorouracil or capecitabine), cisplatin, and pembrolizumab (PDL1 CPS ≥ 10) (category 1)…

Merck...announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1)...The recommendation is based on results from the Phase 3 KEYNOTE-859 trial in which KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in patients whose tumors expressed PD-L1 (CPS ≥1).

Merck...today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA...for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10)....The positive CHMP opinion is based on results from the pivotal Phase 3 KEYNOTE-590 trial...

Pts with previously untreated HER2-negative locally advanced or metastatic G/GEJ adenocarcinoma with known PD-L1 CPS were randomized 1:1 to pembro 200 mg (pembro arm) or pbo...Median OS was 17.3 mo (95% CI, 14.8-19.5) for the pembro arm vs 13.0 mo (11.8-14.4) for the pbo arm (HR, 0.71; 95% CI, 0.58-0.87); median PFS was 8.4 mo (95% CI, 7.2-9.6) for the pembro arm vs 6.7 mo (5.7-6.9) for the pbo arm (HR, 0.69; 0.57-0.85). ORR was 61.2% in the pembro arm and 48.9% in the pbo arm...Consistent with the global KEYNOTE-859 results, the addition of pembro to FP or CAPOX provided improvement in OS, PFS, and ORR numerically, with no new safety signals for pts enrolled in Asia. Results continue to support pembro + chemo as a 1L treatment option for pts with locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma.