For the 380 patients with MSI-H/dMMR non-CRC solid tumors, including genitourinary cancers, the ORR was 33% (95% CI, 28%-38%), with a DOR that ranged from 1.9+ months to 63.9+ months. The ORR was 34% (95% CI, 26%-43%) for the 124 patients with MSI-H/dMMR CRC, with response duration ranging from 4.4 months to over 58.5 months. The median duration of treatment exposure was 6.2 months (range, 1 day-53.5 months) in the KEYNOTE-158 and KEYNOTE-164 trials, and 2.1 months (range, 1 day-25 months) in the KEYNOTE-051 trial. Treatment continued until intolerable toxicity, progressive disease, or up to 24 months. The final 7 patients for the pooled analysis were pediatric patients with MSI-H/dMMR cancers from the KEYNOTE-051 trial.Īll patients were treated with intravenous pembrolizumab every 3 weeks with the doses being 200 mg and 2 mg/kg for adult and pediatric patients, respectively. An additional 373 patients were included from KEYNOTE-158, which enrolled patientswith advanced MSI-H/dMMR non-CRC who progressed after previous treatment were included. These patients had advanced MSI-H/dMMR CRC that progressed after fluoropyrimidine and oxaliplatin or irinotecan with or without a VEGF/EGFR monoclonal antibody–based therapy. The pooled analysis included 124 patients from the KEYNOTE-164 trial. “These data also further underscore the need for biomarker testing to identify patients who may be eligible for this therapy.” Additional supporting data Diaz, Jr., MD, head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, stated in a press release. “This approval reinforces the important role of Keytruda in certain patients with MSI-H or dMMR solid tumors facing a variety of cancers,” Luis A. Among the responders, 77% had a response duration of at least 12 months, and 39% had responses lasting 36 months or longer. The median duration of response (DOR) was 63.2 months (range, 1.9+ to 63.9+). The pooled analysis showed that at 20.1 months’ median follow-up (range, 0.1-71.4), pembrolizumab reached an objective response rate (ORR) of 33.3% (95% CI, 29.2%-37.6%), which consisted of a 10.3% complete response rate and a 23.0% partial response rate. The KEYNOTE-158 population comprised patients with non–colorectal cancer (CRC), including prostate cancer, bladder cancer, and renal cell carcinoma. The conversation to permanent approval was based on a pooled analysis of 504 adult and pediatric patients with over 30 types of cancer enrolled across three phase 2 trials: KEYNOTE-158 (NCT02628067), KEYNOTE-164 (NCT02460198), and KEYNOTE-051 (NCT02332668). The indication, which is for patients with unresectable or metastatic tumors who have progressed following previous treatment and who have no satisfactory alternative options, converts the 2017 accelerated approval of the immunotherapy pembrolizumab in this setting to a full approval.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |