31May

Exelixis reports data from Phase 1b COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Patients With mCRPC

Cabozantinib in combination with atezolizumab in patients with metastatic castrationresistant prostate cancer: Results of cohort 6 of the COSMIC-021 study


Abstract Number : 5564

Abstract Type : Poster Session

Indication : Metastatic Castration Resistant Prostate Cancer

Intervention : Cabozantinib in combination with atezolizumab

Company : Exelixis Inc

Technology : Small Molecule


Result:

Median follow-up as of Dec 20, 2019 was 12.6 mo (range 5, 20) for the 44 mCRPC pts. Median age was 70 y (range 49, 90), 50% had ECOG PS 1, 34% had visceral metastases, and 61% had extrapelvic lymph node metastases. 27% had prior docetaxel and 52% had 2 prior novel hormonal therapies. The most common any grade treatment-related adverse events (TRAEs) were fatigue (50%), nausea (43%), decreased appetite (39%), diarrhea (39%), dysgeusia (34%), and PPE (32%). One grade 5 TRAE of dehydration was reported in a 90 y/o. Median duration of treatment was 6.3 mo. ORR per RECIST 1.1 among all 44 pts was 32% (2 CRs [4.5%] and 12 PRs [27%]); 21 (48%) pts had SD resulting in a disease control rate of 80% in all pts. One pt with PD per RECIST 1.1 had an irPR per irRECIST. ORR per RECIST 1.1 was 33% in 36 pts with high-risk disease (visceral and/or extrapelvic lymph node metastases). Median DOR for all pts with response per RECIST 1.1 was 8.3 mo (range 2.8, 9.8+). 17 (50%) of 34 pts with post-baseline PSA evaluation had a decrease in PSA. In 12 responders with post-baseline PSA evaluation, 8 (67%) had a PSA decrease $50%. Tumor PD-L1 expression will also be reported.


Conclusion:

The combination of C + A had a tolerable safety profile and demonstrated clinically meaningful activity with durable responses in men with mCRPC. Given the encouraging activity in these pts, especially in those with high-risk disease, further evaluation of C + A in men with mCRPC is being pursued.


Commentary:

Cabozantinib and atezolizumab demonstrated clinically meaningful activity in patients with mCRPC including those with high-risk clinical features.


Refer to Metastatic Castration Resistant Prostate Cancer Market report for detailed Insights.