RAHWAY – Merck (NYSE: MRK), known as MSD outside the US and Canada, and the Canadian Cancer Trials Group (CCTG) today announced results from the Phase 3 CCTG-IND.227/KEYNOTE-483 study evaluating KEYTRUDA , Merck’s antibiotic, known -PD-1 therapy plus chemotherapy as first-line treatment for patients with inoperable advanced pleural mesothelioma.
In the final analysis of the study, KEYTRUDA plus chemotherapy significantly improved overall survival (OS) and reduced the risk of death by 21% (HR=0.79). [95% CI, 0.64-0.98]; two-sided p-value = 0.0324) with a median OS of 17.3 months (95% CI: 14.4-21.3) versus 16.1 months (95% CI: 13.1-18.2 ) with chemotherapy alone. This updated data will be presented today during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA8505) and discussed with regulatory authorities worldwide.
“Patients with pleural mesothelioma are usually diagnosed at an advanced stage, when the five-year survival rate is only 12% and curative surgery is not an option,” said Dr. Lesley Seymour, Director of the Investigational New Drug Program at CCTG and Senior Investigator for IND.227. “In our study, the addition of pembrolizumab to platinum-pemetrexed resulted in significantly improved overall survival rates, progression-free survival, and objective response rates compared to platinum-pemetrexed alone, regardless of PD-L1 expression.” patients with advanced pleural mesothelioma.”
“These results support the potential of KEYTRUDA plus chemotherapy as a new first-line option for patients with advanced pleural mesothelioma who currently have limited treatment options,” said Dr. Gregory Lubiniecki, Vice President of Global Clinical Development at Merck Research Laboratories. “These data demonstrate our commitment to improving outcomes for patients with multiple types of breast cancer through our extensive clinical development program and research evaluating KEYTRUDA in emerging, difficult-to-treat tumors.”
Study design and additional data from IND.227/KEYNOTE-483
IND.227/KEYNOTE-483 is a Phase 2/3, randomized, open-label study (ClinicalTrials.gov, NCT02784171) conducted by CCTG in collaboration with the National Cancer Institute of Naples (NCIN) and the Intergroupe Francophone de Cancerologie Thoracique ( IFCT) is sponsored and carried out ). Merck provided KEYTRUDA and support for the study. The study evaluated KEYTRUDA plus chemotherapy versus chemotherapy alone for the treatment of patients with unresected advanced pleural mesothelioma. The primary endpoint of the study is overall survival (OS) and secondary endpoints include progression-free survival (PFS) and objective response rate (ORR) as determined by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) modified for mesothelioma, safety and quality of life. In the phase 3 portion of the study, 440 patients were randomized to receive: KEYTRUDA (200 mg intravenously). [IV] every three weeks [Q3W] for up to 35 cycles) plus pemetrexed (500 mg/m2 Q3W for six cycles) and cisplatin (75 mg/m2 Q3W for six cycles; carboplatin substitution [AUC 5-6 Q3W for six cycles] was allowed) or pemetrexed and cisplatin (carboplatin substitution was allowed) alone.
PFS was also significantly improved with KEYTRUDA plus chemotherapy compared to chemotherapy alone (HR=0.80). [95%CI, 0.65-0.99], two-tailed p-value = 0.0372; mean PFS 7.13 months versus 7.16 months). At 12 months, the estimated PFS rate was 26% for KEYTRUDA plus chemotherapy versus 17% for chemotherapy alone. The ORR was significantly higher for KEYTRUDA plus chemotherapy than for chemotherapy alone (62% vs. 38%, p
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