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The weekend saw several Cabo developments, with the positive announcement of Cabozantinib’s early FDA approval in radioactive iodine- refractory differentiated thyroid cancer (DTC; announced Friday post-close) and several ESMO presentations overshadowed by EXEL’s announcement that, following discussions with the FDA, the company will not pursue an accelerated approval regulatory submission pathway for Cabo+Atezo in metastatic castration-resistant prostate cancer (mCRPC) based on COSMIC-021 Cohort 6. We view this as somewhat surprising given that ESMO data supported initial top-line data in May, though we note that a path-to-market via the ph3 CONTACT-02 study remains intact.
COSMIC-021 demonstrates mPFS of 6.8 mos. for Cabo + atezolizumab (Atezo), but not advancing to regulatory submission in mCRPC. EXEL presented data from Cohort 6 of the Ph1b COSMIC-021 trial of Cabo + Atezo in patients with metastatic castration-resistant prostate cancer (mCRPC), including patients previously treated with novel hormone therapies (NHTs) enzalutimide and/or abiraterone acetate used along with prednisone. New results demonstrate that mPFS per RECIST 1.1 for the high-risk population was 5.6 months (95% confidence interval [CI]: 5.4–8.2) as assessed by investigators and 6.8 months (95% CI: 5.5–9.7) as assessed by Blinded Independent Radiology Committee (BIRC). The exploratory endpoint of OS for the high-risk patient population was 18.4 months (95% CI: 13.6– 24.7). Tumor PD-L1 status, which was known for 75 patients, was not associated with response. Previously announced on 5/24/21, in the high- risk patient population, investigator-assessed ORR was 27%, including 2% complete responses (CRs). The BIRC-assessed ORR was 18%, all partial responses (PRs). The disease control rate (CR + PR + stable disease) was 88% by investigator assessment and 84% by BIRC assessment. Following discussions with the FDA, EXEL will not pursue a regulatory submission for the combination regimen based on Cohort 6 of the COSMIC-021 trial. Pending results, CONTACT-02 may serve as a basis for future regulatory applications in this setting.
Cabo received an early FDA nod for previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC). Based on the findings of a Ph3 COSMIC-311 pivotal trial, the improvement in median PFS (mPFS) vs. placebo vaulted Cabo into yet another approval ahead of schedule (PDUFA action date previously set for 12/4/21). At a planned interim analysis, Cabo significantly reduced the risk of disease progression or death vs. placebo (p<0.0001) in the intent- to-treat population. At a follow-up analysis with a median follow-up of 10.1 months, the mPFS as assessed by blinded independent radiology committee was 11.0 months for patients treated with Cabo (n=170) vs. 1.9 months for patients treated with placebo (n=88); hazard ratio (HR): 0.22; 95% confidence interval (CI): 0.15–0.31. The data presented at the 2021 ESMO Congress reiterated the interim findings from the ASCO Annual Meeting 2021 and published in The Lancet Oncology (HR: 0.22; 96% CI: 0.13–0.36; p<0.0001). Further data from the final analysis also confirmed that superior efficacy with Cabo was maintained irrespective of previous vascular endothelial growth factor receptor (VEGFR)-targeted therapy.