Exelixis Inc - EXEL STOCK NEWS

Exelixis and Ipsen announced the positive results of their pivotal phase 3 COSMIC-312 trial, evaluating cabozantinib with atezolizumab in advanced hepatocellular carcinoma (HCC) patients. The trial met its primary endpoint, showing a 37% reduction in disease progression or death with cabozantinib compared to sorafenib (P=0.0012). However, the secondary endpoint of overall survival did not reach statistical significance, with Exelixis anticipating low probability of achieving this at final analysis, expected in early 2022. The results will inform potential regulatory filing with the FDA.

Exelixis, Inc. (Nasdaq: EXEL) announced that Dr. Gisela M. Schwab, its President and Chief Medical Officer, is on medical leave. Dr. Schwab has been a key figure for 15 years, and her team will continue leading product development and medical affairs during her absence. The company remains focused on 2021 priorities, including upcoming results from the COSMIC-312 trial and potential regulatory filings for cabozantinib. Exelixis, recognized for its oncology innovations, emphasizes a commitment to advancing its drug pipeline while maintaining business continuity.

Exelixis, Inc. (Nasdaq: EXEL) has announced a collaboration with Bristol-Myers Squibb Company for the STELLAR-002 clinical trial, evaluating the combination of XL092 with immuno-oncology therapies for advanced solid tumors. This phase 1b trial will assess the safety and efficacy of XL092, a next-generation tyrosine kinase inhibitor, alongside nivolumab, ipilimumab, and bempegaldesleukin in patients with genitourinary cancers. The trial aims to explore treatment options for those with limited options following disease progression.

Exelixis and Ipsen announced detailed results from the phase 3 COSMIC-311 trial of cabozantinib (CABOMETYX®) in treating radioactive iodine-refractory differentiated thyroid cancer. The trial met its co-primary endpoint, showing a 78% reduction in disease progression risk compared to placebo. Median progression-free survival (PFS) was not reached for cabozantinib, while it was 1.9 months for placebo. The FDA has received a supplemental New Drug Application for cabozantinib, aiming to address urgent treatment needs in this patient population.

Exelixis, Inc. (NASDAQ: EXEL) reported encouraging Phase 2 trial results for CABOMETYX^® (cabozantinib) combined with OPDIVO^® (nivolumab) in treating advanced non-clear cell renal cell carcinoma (nccRCC). The regimen showed a 47.5% objective response rate (ORR) in patients with papillary histology. The trial involved 47 patients with median follow-up of 13.1 months. Adverse events were noted in 17% of CABOMETYX and 13% of OPDIVO patients, with hypertension and diarrhea being the most common severe reactions. This data will be presented at the 2021 ASCO Annual Meeting.

Exelixis announced positive results from a post-hoc exploratory analysis of the phase 3 CheckMate -9ER trial, showing that CABOMETYX (cabozantinib) combined with OPDIVO (nivolumab) is effective across various patient subgroups with advanced renal cell carcinoma (RCC). This analysis highlights improved efficacy metrics, with median progression-free survival (PFS) of 17.0 months for the combination therapy compared to 8.3 months for sunitinib. The data will be presented at the ASCO 2021 Annual Meeting. The results support CABOMETYX and OPDIVO as viable first-line treatment options.

Exelixis, Inc. (NASDAQ: EXEL) announced positive results from a post-hoc analysis of the phase 3 CheckMate -9ER trial, showing that CABOMETYX® (cabozantinib) combined with OPDIVO® (nivolumab) significantly improves quality-adjusted survival for untreated advanced renal cell carcinoma (RCC) patients compared to sunitinib. The analysis revealed a Q-TWiST gain of 4.0 months, translating to a 16.9% relative gain. Key findings include improved time without symptoms and better overall quality of life, addressing the need for advanced kidney cancer treatments that enhance both efficacy and quality of life.

Exelixis, Inc. (Nasdaq: EXEL) will participate in several virtual investor conferences in June 2021. Key presentations include:

• William Blair 41st Annual Growth Stock Conference on June 2 at 5:00pm EDT.
• Goldman Sachs 42nd Annual Global Healthcare Conference on June 9 at 1:20pm EDT.
• BofA Securities 2021 Napa Biopharma Virtual Conference on June 16 at 1:30pm EDT.

Webcast links are available on www.exelixis.com. Exelixis focuses on developing cancer therapies and has several marketed products, including CABOMETYX®.

Exelixis (NASDAQ: EXEL) announced results from cohort 6 of the COSMIC-021 trial, focusing on cabozantinib combined with atezolizumab for metastatic castration-resistant prostate cancer (CRPC). The trial included 132 patients, with a primary endpoint of objective response rate (ORR). High-risk patients showed an ORR of 27%, with a disease control rate of 88%. No new safety signals were observed, and treatment discontinuation due to adverse events was 12%. Exelixis plans to discuss FDA regulatory submission next, following the encouraging results.