Merck?s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as First-Line Treatment for Extensive Stage S
Monday, January 6, 2020 4:05 pm EST
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-604 trial investigating KEYTRUDA, Merck?s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis. At the final analysis of the study, there was also an improvement in overall survival (OS) for patients treated with KEYTRUDA in combination with chemotherapy compared to chemotherapy alone; however, these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.80 [95% CI, 0.64-0.98]). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
?Results of KEYNOTE-604 demonstrated the potential of KEYTRUDA, in combination with chemotherapy, to improve outcomes for patients newly diagnosed with extensive stage small cell lung cancer, a highly aggressive malignancy,? said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. ?We sincerely thank the patients and investigators for their participation in this study and are committed to helping patients who face difficult-to-treat types of lung cancer.?
In addition to KEYTRUDA?s five current indications in lung cancer, Merck is continuing to study KEYTRUDA across multiple settings and stages of lung cancer through a broad clinical program, which is comprised of more than 10,000 patients enrolled or expected to be enrolled across 20 Merck-sponsored clinical studies.
About KEYNOTE-604
KEYNOTE-604 is a randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03066778) investigating KEYTRUDA in combination with chemotherapy compared to chemotherapy alone in patients with newly diagnosed ES-SCLC. The dual primary endpoints were OS and PFS. Secondary endpoints included objective response rate (ORR), duration of response (DOR), safety and quality of life (QoL). The study enrolled 453 patients who were randomized to receive either:
- KEYTRUDA (200 mg fixed dose on Day 1 of each 21-day cycle) in combination with etoposide (100 mg/m2?on Days 1, 2?and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 on Day 1 or cisplatin 75 mg/m2?on Day 1); or
- Placebo in combination with etoposide (100 mg/m2?on Days 1, 2?and 3) and investigator's choice of platinum chemotherapy (carboplatin titrated to AUC 5 mg/mL/min on Day 1 or cisplatin 75 mg/m2?on Day 1).
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
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