KEY TAKEAWAYS
- The phase 3 KEYNOTE-775 trial compared the efficacy of lenvatinib plus pembrolizumab vs treatment of physician’s choice chemotherapy in patients with previously treated advanced endometrial cancer.
- The method used was assigning patients a 1:1 chance of receiving either treatment option and analyzing their PFS and OS using RECIST v1.1 criteria.
- The results showed that patients who received lenvatinib plus pembrolizumab had significantly better PFS, OS, and ORR compared to those who received physician’s choice chemotherapy.
- The study enrolled 155 Asian women with previously treated advanced endometrial cancer, and the treatment-related adverse events were similar between the two groups.
- Lenvatinib plus pembrolizumab showed clinically substantial improvements in PFS, OS, and ORR compared to physician’s choice chemotherapy in Asian women.
Patients with previously treated advanced endometrial cancer (EC) had significantly better progression-free survival (PFS) and overall survival (OS) with lenvatinib (len) + pembrolizumab (pembro) compared to treatment with physician’s choice chemotherapy (TPC) in the worldwide phase 3 Study 309/KEYNOTE-775 (NCT03517449). Researchers reported on the prespecified efficacy analysis results for the Asian subgroup in Study 309/KEYNOTE-775. Patients who satisfied the inclusion criteria had to be female and less than 18 years of age, with histologically confirmed advanced, recurrent, or metastatic EC with PD after 1 prior platinum-based chemo treatment (2 if 1 given in neoadjuvant or adjuvant setting). Patients were assigned a 1:0 chance of receiving either TPC (doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV Q3W [3 weeks on/1 week off]) or len 20 mg PO QD plus pembro 200 mg IV Q3W (up to 35 cycles). Patients with pMMR disease were initially categorized by MMR status (pMMR or dMMR) and subsequently by ECOG PS, geographic location, and history of pelvic radiation. PFS, as measured by BICR’s RECIST v1.1 and OS, were the primary objectives. There are no predictive analyses.
A total of 155 patients were enrolled from Japan, Taiwan, and South Korea; 134 patients had pMMR disease (len + pembro, n = 66; TPC, n = 68). Data were collected from January 1, 2020, through March 1, 2022, with a median of 34.3 months (range 25.1-43.0 months). The table displays the effectiveness data for both patients with pMMR illness and all-comer patients. Treatment-related adverse events (AEs) of grade 3 or higher occurred in 74.0% of len + pembro patients and 72.0% of TPC patients, respectively, among all-comer patients. 14% versus 48% of all-comer pts, respectively, received later anticancer treatment, and 3% versus 15.5% received a PD-(L)1 inhibitor. Clinically substantial improvements in PFS, OS, and ORR versus TPC were seen in Asian women with previously treated advanced EC, similar to the global research group, with tolerable tolerability.
Source:https://oncologypro.esmo.org/meeting-resources/esmo-asia-congress/lenvatinib-plus-pembrolizumab-versus-treatment-of-physician-s-choice-in-patients-with-previously-treated-advanced-endometrial-cancer-study-309-key
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03517449
K. Yonemori, K. Fujiwara, K. Hasegawa, M. Yunokawa, K. Ushijima, S. Suzuki, A. Shikama, S. Minobe, T. Usami, J. Kim, B. Kim, P. Wang, T. Chang, K. Yamamoto, S. Han, J. McKenzie, G. Barresi, T. Miura, V. Makker, Y.M. Kim/Lenvatinib plus pembrolizumab versus treatment of physician’s choice in patients with previously treated advanced endometrial cancer: Study 309/KEYNOTE-775 Asian subgroup/Annals of Oncology (2022) 33 (suppl_9): S1503-S1514. 10.1016/annonc/annonc1126
