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LBA Cosmic 021I assume we will see updated data over the weekend, here is what the abstract shows (just released at 6:05). Background C may enhance response to immune checkpoint inhibitors by promoting an immune-permissive microenvironment. COSMIC-021 (NCT03170960), a multinational phase 1b study, is evaluating C + A in solid tumors, including mCRPC, which has limited treatment options after failure of novel hormonal therapy (NHT). We report efficacy and safety results of expanded cohort 6 in mCRPC. MethodsEligible pts had measurable disease, radiographic progression in soft tissue after enzalutamide and/or abiraterone, and ECOG PS of 0 or 1. Prior chemotherapy for metastatic castration-sensitive prostate cancer (mCSPC) was permitted. Pts received C 40 mg PO QD and A 1200 mg IV Q3W. CT/MRI scans were performed Q6W for 52W and Q12W thereafter. The primary endpoint was ORR by investigator (INV) per RECIST 1.1. Other endpoints included safety, PFS, and OS. ResultsAs of the data cutoff of 19 Feb 2021, 132 mCRPC pts were enrolled with a median (range) follow-up of 15.2 mo (5.7, 33.9). Median age was 70 y, 68 (52%) had ECOG PS 0, and 101 (77%) had measurable visceral metastases (mets) and/or extrapelvic lymphadenopathy (EPLN); 42 (32%) had visceral mets and 79 (60%) had EPLN; 33 (25%) had prior docetaxel for mCSPC, and 59 (45%) had received ≥2 prior NHT. Frequent treatment-related adverse events (TRAEs) were diarrhea (55%), nausea (42%), fatigue (43%) and decreased appetite (34%). Grade 3/4 TRAEs occurred in 55%; one grade 5 TRAE of dehydration was reported in a 90 y/o. ORR by INV among all pts per RECIST 1.1 was 23% with 3 CRs; ORR by independent review (BIRC) was 15% (all PRs); DCR (CR + PR + SD) was 84% by INV and 81% by BIRC. In pts with visceral mets and/or EPLN, ORR by INV was 27% with 2 CRs and 18% by BIRC (all PRs); DCR was 88% by INV and 84% by BIRC. Median PFS per RECIST 1.1 by BIRC was 5.7 mo in all pts and 6.8 mo in pts with visceral mets and/or EPLN; median OS was 18.4 mo in both groups. Preliminary data do not suggest an association between tumor PD-L1 status (known for 75 pts) and anti-tumor activity. ConclusionsC + A demonstrated clinically meaningful activity with a manageable safety profile in mCRPC, supporting a phase 3 study of C + A versus second NHT (CONTACT-02; NCT04446117). |
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