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The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.
Merck discontinued the phase 3 KeyVibe-008 (NCT05224141) trial based on the recommendation of an independent data monitoring committee, according to a news release. The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab (Keytruda; Merck) in combination with chemotherapy compared with atezolizumab (Tecentriq; Genentech) in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).1
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“Small cell lung cancer remains a difficult disease to treat, as evident by the 7% 5-year survival rate and limited advancements in treatment options,” Marjorie Green, MD, senior vice president and head of oncology of global clinical development at Merck Research Laboratories, said in the news release. “Innovative research plays a critical role in improving our understanding to help patients achieve better outcomes, and while we hoped the results would be different, we remain committed to investigating novel approaches to treat this debilitating disease.”1
At the pre-planned analysis, results showed that overall survival (OS) met the prespecified futility criteria, with individuals in the vibostolimab and pembrolizumab group experiencing higher rates of adverse events and immune-related AEs, according to the news release. The comprehensive analysis remains ongoing.1
Merck will be informing investigators that individuals in the experimental arm should halt treatment and may cross over to receive atezolizumab and chemotherapy.2
The study was a multicenter, randomized, double-blind trial that enrolled individuals aged 18 years and older who had histologically or cytologically confirmed and previously untreated ES-SCLC. Patients had a disease measurable by RECIST v1.1 and provided a pretreatment tumor sample. Treatment was randomized 1:1 for up to 4 cycles of etoposide/platinum therapy (either cisplatin or carboplatin) in combination with vibostolimab and pembrolizumab (both 200 mg) every 3 weeks or atezolizumab 1200 mg every 3 weeks. Treatment was followed with either the study combination or atezolizumab until disease progression, unacceptable AEs, intercurrent illness, protocol violation, or investigator/patient decision, according to the study authors.3
The primary end point was OS, with secondary end points including progression-free survival, overall response rate, duration of response, safety, and patient-reported outcomes.3 Merck is expected to share full data from the study at a later date because the analysis is still ongoing.2
Trial Name: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)
ClinicalTrials.gov ID: NCT05224141
Sponsor: Merck Sharp & Dohme LLC
Completion Date (Estimated): June 2027
Currently, there are ongoing phase 3 studies evaluating the combination for lung cancer, including KeyVibe-003, KeyVibe-006, and KeyVibe-007. An external data monitoring committee have not reviewed safety analysis in any study modification. Merck reported that the studies are undergoing comprehensive safety monitoring.1
Merck has several clinical development programs in lung cancer, including the IDeate-Lung02 (NCT06203210), which will be assessing the efficacy and safety of ifinatamab deruxtecan (I-DXd; Daiichi Sankyo) for SCLC. The companies reported that the first patient has been dosed.4
