Source – Merck
A new combination therapy for patients with advanced gastric or GEJ cancer that is positive for both HER2 and PD-L1 has received a positive opinion from the CHMP of the EMA. The therapy consists of pembrolizumab (Keytruda), an immunotherapy drug, plus trastuzumab (Herceptin), a targeted therapy, and chemotherapy. The CHMP’s recommendation is based on the interim results of the phase 3 KEYNOTE-811 trial (NCT03615326), which showed that adding pembrolizumab to trastuzumab and chemotherapy significantly improved PFS and ORR compared with trastuzumab and chemotherapy alone in this patient population. The trial also suggested a potential benefit in OS with pembrolizumab, but this was not statistically significant.
The European Commission will review the CHMP’s recommendation and decide whether to grant marketing authorization to this combination therapy in the EU by the third quarter of 2023. The KEYNOTE-811 trial is a randomized, double-blind phase 3 study that enrolled about 732 patients with locally advanced, unresectable or metastatic HER2-positive gastric or GEJ cancer. Patients were randomly assigned to receive either pembrolizumab or placebo every 3 weeks, along with trastuzumab and chemotherapy based on fluoropyrimidine and platinum. The primary end points of the study are OS and PFS. Secondary end points include ORR, duration of response, and safety.
“Today’s positive CHMP opinion is the next step for gefapixant to become the first treatment approved in the European Union for adults with refractory or unexplained chronic cough. Refractory or unexplained chronic cough as a condition with often disruptive, uncontrolled coughing associated with major physical, social and emotional consequences represents a large unmet clinical need.”
– Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories
To be eligible for the trial, patients had to be 18 years or older, have confirmed HER2-positive gastric or GEJ cancer by central review, have measurable disease by RECIST v1.1 criteria, have a life expectancy of more than 6 months, have adequate organ function, and have an ECOG performance status of 0 or 1 within 3 days of study entry. Pembrolizumab plus trastuzumab and chemotherapy has already been approved by the FDA for this indication in May 2021 under accelerated approval.3 This approval was based on the same data from the KEYNOTE-811 trial. The continued approval of this regimen depends on confirming its clinical benefits in further trials.
