Array BioPharma’s (ARRY) transition into a commercial stage pharmaceutical company appears to be going smoothly, as the company reported an encouraging rollout of the Braftovi/Mektovi combination for metastatic melanoma. Importantly, the company announced that they’ve observed a large number of US prescribers switch their patients from the standard-of-care for BRAF-mutant melanoma, the combination of Tafinlar/Mekinist, to Braftovi/Mektovi, driven largely by results seen in the COLUMBUS trial. In this trial, Braftovi/Mektovi showed the best inclass numerical results for overall survival seen to date in BRAF-mutant patients, as well as a favorable toxicity profile.
Going into 2019, Array emphasized the importance of the Phase III BEACON trial, evaluating the combination of Braftovi/Mektovi/cetuximab in previously-treated BRAF-mutant colorectal cancer (CRC). As the number of treatable patients in this indication exceeds the number of treatable patients in melanoma, approval for this indication is seen by the company as a larger value-driver.
With enrollment for this trial completed, Array expects top-line results of an interim analysis to be release in H1 2019, and announced that they plan to seek accelerated approval in the US if results of this analysis are positive. The combination received the FDA’s Breakthrough Therapy designation for CRC in August of 2018 based on results from BEACON’s safety lead-in.
Array also discussed their partnerships with Bristol-Myers Squibb, Merck, and Pfizer, testing Mektovi combinations in previously-treated, RAS-mutant, microsatellite stable (MSS) CRC, first-or second-line MSS CRC, and previously-treated pancreatic cancer/non-small cell lung cancer, respectively. Though these trials are exploratory in nature, they have the potential to drive significant value for Array.
Going into 2019, Array emphasized the importance of the Phase III BEACON trial, evaluating the combination of Braftovi/Mektovi/cetuximab in previously-treated BRAF-mutant colorectal cancer (CRC). As the number of treatable patients in this indication exceeds the number of treatable patients in melanoma, approval for this indication is seen by the company as a larger value-driver.
With enrollment for this trial completed, Array expects top-line results of an interim analysis to be release in H1 2019, and announced that they plan to seek accelerated approval in the US if results of this analysis are positive. The combination received the FDA’s Breakthrough Therapy designation for CRC in August of 2018 based on results from BEACON’s safety lead-in.
Array also discussed their partnerships with Bristol-Myers Squibb, Merck, and Pfizer, testing Mektovi combinations in previously-treated, RAS-mutant, microsatellite stable (MSS) CRC, first-or second-line MSS CRC, and previously-treated pancreatic cancer/non-small cell lung cancer, respectively. Though these trials are exploratory in nature, they have the potential to drive significant value for Array.
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