Combination does not extend survival vs. chemotherapy in gastroesophageal cancer
The addition of lenvatinib and pembrolizumab to chemotherapy did not extend OS for certain patients with advanced gastroesophageal adenocarcinoma, according to the agents’ manufacturers.
However, the combination did confer statistically significant improvement in PFS and objective response rate.
Pembrolizumab (Keytruda, Merck) is a PD-1 inhibitor. Lenvatinib (Lenvima, Eisai) is a multikinase inhibitor.
Researchers conducted the randomized phase 3 LEAP-015 trial to assess the efficacy and safety of chemotherapy alone or in combination lenvatinib and pembrolizumab for treatment of locally advanced unresectable or metastatic HER2-negative gastroesophageal adenocarcinoma.
Patients in the control arm received chemotherapy alone.
Those assigned the investigative regimen completed an approximately 12-week induction phase in which they received 400 mg pembrolizumab via IV every 6 weeks for two cycles plus 8 mg oral lenvatinib daily plus chemotherapy. In the consolidation phase, they received 400 mg pembrolizumab via IV every 6 weeks for up to 16 doses, plus 20 mg oral lenvatinib daily.
OS and PFS served as primary endpoints. ORR and duration of response served as secondary endpoints.
A prior interim analysis showed PFS and ORR improvements with pembrolizumab-lenvatinib. However, the final analysis showed no OS benefit.
“Gastric and gastroesophageal cancers continue to present challenges due to their heterogeneity and generally poor prognoses,” Corina Dutcus, MD, senior vice president and oncology global clinical development lead at Eisai, said in a press release. “While the LEAP-015 trial did not show a statistically significant increase in overall survival, we were pleased to observe an improvement in progression-free survival and objective response rate.”
The combination exhibited a safety profile consistent with that observed in previous trials.
Complete data from LEAP-015 will be presented at a medical meeting.