While ESMO 2021 annual meeting is nearby, pharma giants, namely AstraZeneca, Seagen, Merck, Verastem Oncology, Zentalis Pharmaceuticals, Corcept, GSK, and others, are looking at this opportunity to present their data readouts for different gynecological cancers. Keytruda (pembrolizumab), an anti-PD-1 blockbuster therapy by Merck, is already approved in multiple indications, including an accelerated approval as a 2L treatment in cervical cancer. In cervical cancer, Keytruda is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
KEYNOTE-826 trial: Pembrolizumab plus Chemotherapy as First-line Treatment in Women with Persistent, Recurrent, or Metastatic Cervical Cancer
The KEYNOTE-826, a phase III trial, is being conducted to demonstrate the safety and efficacy of Keytruda in a 1L setting. It is also the confirmatory trial for the current accelerated approval for Keytruda in cervical cancer for the second-line treatment of patients. In this study, Keytruda plus chemotherapy with or without Roche’s Avastin (bevacizumab) or paclitaxel plus carboplatin is being studied.
In June 2021, based on an interim analysis conducted by an Independent Data Monitoring Committee, the company announced that the study met its dual primary endpoint of overall survival (OS) and progression-free survival (PFS). Although the complete data is yet to be presented but it is expected that a large number of patients might switch to Keytruda upon approval, and the probability of success remains high based on its past approval along with satisfactory primary endpoints achievement. The company is prepared to present the data from the KEYNOTE-826 Phase III trial (Abstract LBA2) at the upcoming ESMO 2021.
Expert Opinion: “Women diagnosed with metastatic cervical cancer have a particularly poor prognosis, and there is an urgent need for new treatment options. KEYNOTE-826 is the first study to show positive results for immunotherapy in first-line persistent, recurrent or metastatic cervical cancer, and we look forward to sharing these findings at an upcoming congress and discussing them with regulatory authorities.”
– Senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories
The approval of a PD-1 therapy such as Keytruda in the 1L setting will reduce the appeal of the other PD-1 therapies in 2L setting, such as Agenus’s Balstilimab (anti-PD-1 antibody), which is currently under priority review by the FDA along with Sanofi’s Libtayo (anti-PD-1), which is eyeing the regulatory submission in 2021. Both drugs (Libtayo and balstilimab) are effective regardless of the biomarker status, with Libtayo having an OS advantage of 31% over chemotherapy. The Keytruda combination is also attractive as it makes minimal changes in the 1L SOC setting with its mere addition to the current chemotherapy regimen. Roche’s Tecentriq, another checkpoint inhibitor, a competitor to Keytruda, is in a similar phase III BEATcc study for 1L setting with March 2023 as the primary completion date. We expect Keytruda to lead in the 1L persistent, recurrent or metastatic cervical cancer following ESMO data readout in the upcoming days.