Plimack and colleagues performed a post-hoc exploratory analysis to evaluate the association between depth of response and OS. Researchers observed the benefit with the combination in all subgroups tested. Median duration of response was 23.5 months (range, 1.4+ to 34.5+) with the combination vs. These are landmark survivals that we haven’t really seen in kidney cancer to date.”Ī higher percentage of patients assigned pembrolizumab-axitinib than sunitinib achieved objective response (60% vs. “Those results continue to impress with the combination and continue to be superior to sunitinib. “Second, HR is one way to measure benefit, but another is to look at these landmarks and see how many people make it to 1 year or 2 years,” Plimack added. First, to show an early benefit actually ends up helping more patients than showing a late benefit. “I would say a couple things in response to that. “Some people mention how the HR numerically changed - it was 0.53 and now it is 0.68 - and how that seems to show the difference between the two groups is narrowing over time,” Plimack said. Results continued to show a statistically significant benefit with pembrolizumab-axitinib with regard to median OS (not reached vs. The FDA approved the combination for first-line treatment in April 2019 based on these results.Īt ASCO, Plimack presented updated analyses based on median follow-up of 27 months (range, 0.1-38.4). Median OS had not been reached in either group, but the early results showed a significant benefit with pembrolizumab-axitinib (HR = 0.53 95% CI, 0.38-0.74). Secondary endpoints included overall response rate, duration of response and safety.Īt last year’s Genitourinary Cancers Symposium, Plimack and colleagues presented results of the first preplanned interim analysis based on median follow-up of 12.8 months.Īs Healio previously reported, the pembrolizumab-axitinib combination appeared associated with improvements in median PFS (15.1 months vs. OS and PFS served as co-primary endpoints. poor) and geographic region (North America vs. Researchers stratified randomization by International Metastatic RCC Database Consortium (IMDC) risk (favorable vs. Treatment continued until disease progression, unacceptable toxicity or withdrawal. The other 429 patients received 50 mg oral sunitinib daily in a 4-weeks-on, 2-weeks-off schedule.
#Keynote 426 plus
Researchers randomly assigned 432 patients to 200 mg pembrolizumab IV every 3 weeks for a maximum 35 cycles plus 5 mg oral axitinib twice daily. The study included 861 patients (median age, 62 years 73% men) who had Karnofsky performance scores of at least 70%. The phase 3 KEYNOTE-426 study compared the pembrolizumab-axitinib combination with sunitinib as first-line therapy for previously untreated advanced or metastatic clear-cell renal cell carcinoma.
#Keynote 426 trial
However, a phase 1/phase 2 trial showed the combination of the PD-1 inhibitor pembrolizumab and the VEGF-targeted tyrosine kinase inhibitor axitinib could be an effective and safe option. Many early combinations of checkpoint inhibitors and VEGF inhibitors were associated with unacceptable toxicity. VEGF inhibition and checkpoint inhibition are active in kidney cancer. That relationship did not hold true with sunitinib.” In the combination group, the deeper the response, the longer patients tended to survive. Plimack, MD, MS, chief of the division of genitourinary medical oncology, associate professor in the department of hematology/oncology and director of genitourinary clinical research at Fox Chase Cancer Center, told Healio. “It is encouraging that, with longer follow-up, we see the patients who received the combination continue to achieve better PFS and OS,” Elizabeth R. Researchers observed no new safety signals with the combination. The benefit with pembrolizumab (Keytruda, Merck) and axitinib (Inlyta, Pfizer) compared with sunitinib (Sutent, Pfizer) persisted across all subgroups. If you continue to have this issue please contact to Healioįirst-line pembrolizumab plus axitinib extended survival among patients with advanced renal cell carcinoma, according to updated results of the randomized phase 3 KEYNOTE-426 study presented during the ASCO20 Virtual Scientific Program.
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