Exelixis, Inc. (EXEL) stock prices were down by a significant 19.46% as of the market opening on June 28th, 2021, bringing the price down to USD$18.86 early on in the trading day.
COSMIC-312 Trial
June 28th, 2021 saw EXEL announced that its COSMIC-312 Phase 3 pivotal trial met a primary endpoint, wherein the treatment demonstrated substantial improvement in progression-free survival at the planned primary analysis. The trial is designed to evaluate CABOMETYX in combination with atezolizumab versus sorafenib in patients reporting untreated advanced hepatocellular carcinoma.
Interim Analysis
Being conducted concurrently, a prespecified interim analysis for the secondary endpoint of overall survival indicated results that favored a CABOMETYX and atezolizumab combined treatment. The data did not reach statistical significant and the company does not expect a high probability of the final analysis resulting in the reaching of statistical significance. The trial is currently ongoing, with plans to continue through to the final analysis of OS, the results of which are forecasted for early 2022.
Strength of Combined Treatment
In the evaluation of the primary endpoint of PFS in the PFS intent-to-treat population, the risk of disease progression or death was 37% lower with CABOMETYX in conjunction with atezolizumab, as compared to treatment with CABOMETYX and sorafenib. The combined treatment’s safety was consistent with existing safety profiles of the individual medicines, with no new safety signals being identified. The company is discussing trial results while strategizing its next steps for regulatory filing with the U.S. FDA.
Shortcomings of Treatment
While the combined treatment of CABOMETYX in conjunction with atezolizumab has indicated encouraging results for the reduction of the risk of disease progression or death, it fell short of proving significant improvement in OS as compared to the comparator arm. The company is exploring the data it has generated, identifying factors that contributed to the results, including patient demographics, subsequent anti-cancer therapy, and the effects of the pandemic on the trial.
Scope of Treatment
With more than 900,000 new cases of liver cancer being diagnosed around the world annually, 90% of the cases are HCC. HCC is a leading cause of cancer-related fatalities, with forecasts of the disease claiming 1 million lives every year by 2030. It is the fastest-rising cause of cancer-related death in the U.S, with patients having a median survival period of 1-1.5 years.
Future Outlook for EXEL
With the recent developments with its highly-anticipated trial, EXEL is poised to capitalize on the opportunities afforded to it in order for it to bounce back stronger than ever. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
