In the monotherapy arm, 40 (90.4%) patients had ongoing treatment and 385 (90.6%) had discontinued.Īt the median follow-up of 42.8 months (range, 35.6-50.6), 204 patients in the combination arm received subsequent treatment with 3 who completed the regimen there were 201 patients who discontinued treatment. ![]() In the combination arm, 18 (4.2%) patients completed treatment, 62 (14.5%) patients had ongoing treatment, and 349 (81.4%) patients discontinued. There were 432 patients assigned to the combination arm and 429 were treated there were 429 patients assigned to the monotherapy arm, with 425 patients receiving treatment. The investigators report that patients were assumed to be at a similar stage of disease in stage 1, ie, TSE model without recensoring.Īt the data cutoff of January 21, 2021, 861 patients were randomly assigned to receive either pembrolizumab plus axitinib or sunitinib. Survival time was adjusted multiplicatively by the acceleration factor that was determined in stage 1 of the trial. In stage 2, survival time was determined after patients received the combination treatment of pembrolizumab and axitinib vs sunitinib. Using a 2-stage estimation (TSE) model, investigators determined the effect, called the acceleration factor, of subsequent anticancer therapy for patients in KEYNOTE-426 (stage 1). The findings, which showed a benefit for the immunotherapy/TKI regimen in adjusted overall survival (OS) as well as in the type and timing of subsequent therapy, were shared in a poster during the 2021 ESMO Congress by principal investigator Rustem Gafanov, MD, Russian Scientific Center of Roentgenoradiology, and his coinvestigators. In the overall population, risk of death was reduced by 23%.The latest results of the phase 3 KEYNOTE-426 study offered further insight into the extent of the benefitof pembrolizumab (Keytruda) plus axitinib (Inlyta) over single-agent sunitinib (Sutent) in patients with clear cell renal cell carcinoma (ccRCC). In patients with higher levels of PD-L1, the survival figure increased to 39%. Results showed Keytruda could cut risk of death by 22% compared with standard of care in patients testing positive for the PD-L1 biomarker. The regulator will grant a faster six-month review, as opposed to the standard ten-month period, based on trial results presented at the European Society for Medical Oncology (ESMO) meeting in October. The companies had already indicated that the trial had been a success in October, but this interim analysis suggests that BMS and Opdivo could face tough competition in kidney cancer if Keytruda is approved in this indication.įull results from KEYNOTE-426 will be presented at a forthcoming medical meeting.Īnd in a separate development the FDA has also given Keytruda a Priority Review in first-line head and neck cancer, alone or in combination with chemotherapy. 10.1% of patients in those arms, respectively. 58.1% in the sunitinib arm and led to regimen discontinuation in 6.3% vs. Treatment-related adverse events were grade 3-5 in 62.9% of patients in the Keytruda and Inlyta arm vs. The combination significantly increased progression-free survival and overall response rate, and results were consistent across all risk groups, and regardless of expression of the biomarker PD-L1. ![]() Results from the phase 3 KEYNOTE-426 show that the combination of Keytruda and Inlyta reduced risk of death in renal cell carcinoma by around 47%, compared with Pfizer’s established cancer drug Sutent (sunitinib). Merck is looking to compete in this indication by combining Keytruda with Pfizer’s cancer drug Inlyta (axitinib). Opdivo, in combination with BMS’ Yervoy (ipilimumab) is already approved in intermediate or poor-risk patients with untreated advanced renal cell carcinoma. Keytruda’s sales advantage over rival immunotherapy Opdivo is based around its approval in the lucrative first-line lung cancer indication, where BMS’ drug has failed to produce convincing trial results.īut US-based Merck & Co is trying to press home this advantage by getting Keytruda (pembrolizumab) approved in a range of other cancer indications, including those where Opdivo (nivolumab) already has a foothold. Merck & Co and its cancer immunotherapy Keytruda has gained a double boost in its tussle with rival Bristol-Myers Squibb, with positive results in kidney cancer, and the promise of an FDA fast review in head and neck cancer.
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