![]() ![]() For performance status, they were all 0 to 1 with most of it being 0. Most of the patients were MMR proficient, about 84%, with about 16% being MMR deficient. The bar is always moving, but it’s an area that we need to pay much more attention to, so I’ll put that out there. ![]() In some of these trials, it’s very complicated because some of are molecularly based, where patients have to have a certain mutation and there are differences in the rates of mutations in different populations. We are actively engaged with the FDA as to what success looks like in this area because it varies. We’ve organized a committee around this, with Bhavana Pothuri, MD, from NYU Langone Health who has been named our Diversity Equity Inclusion officer. I’m involved with the GOG Foundation and we take this seriously. This is an area where the FDA has come out and they want diversity plans for all clinical trials moving forward. We’re looking at a target goal of 15% to 20%, and this was very under-enrolled at. Unfortunately, this trial was under-enrolled for Black patients. Many of the demographic baseline characteristics have prognostic implications for endometrial cancer. The primary end point was progression-free survival by BICR with a coprimary end point of overall survival. They stratified based on MMR status, region of the world, performance status, and whether they had radiation therapy in their history. They had performance status of 0 or 1 and they all had MMR testing. The investigators did blinded independent central review for assessment of response or progression. These were patients with advanced metastatic or recurrent endometrial cancers. was doxorubicin or paclitaxel, given on a weekly basis for the paclitaxel with 3 weeks on and 1 week off. Most of these patients have had carboplatin/paclitaxel. Carboplatin/paclitaxel is not the control arm here. 1 This is the phase 3 trial with 1:1 randomization, looking at chemotherapy versus lenvatinib/pembrolizumab. The data came out in the New England Journal of Medicine, very exciting data. Targeted Oncology TM: Which trial data supports the use of lenvatinib (Lenvima) and pembrolizumab (Keytruda) in patients with advanced, metastatic, or recurrent endometrial cancer? ![]()
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