Array BioPharma Inc. ARRY announced that its late-stage study, which evaluated the combination of Braftovi and Mektovi plus Lilly’s LLY Erbitux (cetuximab) has met the primary endpoint of objective response rate (ORR) and overall survival (OS). The phase III BEACON CRC study examined the Braftovi triplet for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) following one or two prior lines of therapy.
Shares of Array BioPharma were up almost 23% post announcement of the news on Tuesday. In fact, the stock has skyrocketed 80.9% so far this year, outperforming the industry’s rise of 0.3%.
Data from the study showed that BRAF-mutant mCRC patients, treated with the Braftovi triplet, demonstrated a statistically significant improvement in ORR and OS compared with those having received Erbotux plus irinotecan-containing regimens (called the control arm). The outcomes showed that the Braftovi triplet lowered the risk of death by 48% as compared to the control arm. The median overall survival stood at 9 months in the Braftovi triplet arm compared with the control arm.
Currently, there are no FDA-approved treatments available for the given patient population. The data clearly shows a significant improvement compared with the available standard of care options for this patient population. Array BioPharma plans to submit these findings for a marketing approval in the second half of 2019.
Meanwhile, data obtained from the secondary endpoint analysis showed that patients treated with the combo of Braftovi and Erbitux (Braftovi doublet) also demonstrated a statistically significant improvement in ORR and OS as compared to the control arm. Both the BRAFTOVI triplet and the doublet were generally well-tolerated with no unexpected toxicity reported.
Meanwhile, a phase II study is evaluating the combination of Braftovi and Mektovi plus Erbitux in first-line mCRC with similar mutation. The study is expected to be completed in late 2020.
We would like to remind investors that last June, the combination of Braftovi plus Mektovi was approved for treating unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. The drug combination was launched last July 2018 in the United States and the same was approved in Europe last September. It generated almost $72 million in its first three commercial quarters and registered sequential growth of more than 50% in the quarter ending March 2019.
In February 2019, the therapy was approved in Japan for unresectable melanoma with a BRAF mutation.
Notably, during the first quarter of 2019, the company amended the protocol of the BEACON CRC study to include an interim analysis of study endpoints, based on inputs from the FDA and the European Medicines Agency. In March 2019, the combination of Braftovi and Mektovi plus Erbitux was added to the NCCN (National Comprehensive Cancer Network) guidelines as a treatment option for advanced BRAF-mutant colorectal cancer.
Array BioPharma also has immuno-oncology study collaborations with Bristol-Myers BMY, Merck MRK and Pfizer. Additional clinical studies have started to evaluate Braftovi and Mektovi for BRAF V600 mutant melanoma brain metastases and non-small cell lung cancer (NSCLC).
Array BioPharma currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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