Array obtained positive results for its phase 3 BEACON CRC study using BRAFTOVI, METKOVI, and ERBITUX to treat patients with BRAF mutant metastatic colorectal cancer.
Treatment with the BRAFTOVI triplet by Array was statistically significant in both objective response rate and overall survival compared to control in patients with BRAF mutant metastatic colorectal cancer.
Fiscal third-quarter sales for BRAFTOVI plus MEKTOVI came in at $35.1 million, which was an increase of 54% from second-quarter sales of $22.7 million.
Array has approximately $479 million in cash, cash equivalents and marketable securities as of March 31, 2019.
Array BioPharma (ARRY) announced positive interim results from its phase 3 study using BRAFTOVI along with several other drugs in patients with BRAF V600E mutant metastatic colorectal cancer (mCRC). This pushes the company to file a regulatory application for marketing approval by the second half of 2019. Two of the drugs, which obtained positive results in a triplet for mCRC, were already approved for patients with unresectable or metastatic melanoma associated with a BRAFV600E or a V600K mutation back in June of 2018. This latest positive data, along with potential approval, will help push drug sales for BRAFTOVI and METKOVI higher.
Phase 3 Results Make Case For FDA Approval
The phase 3 study was known as the BEACON CRC trial. It evaluated a triple combination of BRAFTOVI, MEKTOVI and ERBITUX (also known as BRAFTOVI triplet) in patients with BRAF V600E mutant mCRC. The trial met on both the primary and secondary endpoints. One of the primary endpoints was the overall survival (OS), while one of the secondary endpoints was objective response rate (ORR). One thing to know is that the BRAFTOVI triplet was being compared to control. Control was established as ERBITUX (cetuximab) plus irinotecan containing regimens. It was shown that treatment with the BRAFTOVI triplet by Array was statistically significant in both ORR and OS compared to control. In terms of ORR, it was 26.1% for those on triplet compared to 1.9% on control. Then in terms of OS it was a median of 9 months for triplet treatment versus 5.4 months for those given control. Both of these endpoints were statistically significant with a p-value of p<0.0001. This data is pretty good, but there is an even more pressing issue on why this trial is promising for these patients. These types of patients tend not to respond well when given standard of care therapies. Specifically, there are no FDA approved therapies for this patient population. The ability to get a more targeted treatment approach out to these patients is highly ideal. While standard of care treatments have done a decent job, they don't work as well as targeted therapies for specific mutations. For instance, in this instance a BRAF inhibitor and MEK inhibitor are specifically developed to halt mutations from activating the cell-signaling pathway known as MAPK.
Potential Expansion Opportunity
The thing is that Array BioPharma is already generating revenue for its duo drug combo of BRAFTOVI and METKOVI for melanoma. The drug combination has already been approved for sale in many territories. It's been approved in the U.S., Europe, Australia. On top of that, there is another market to obtain sales for. For example, Array launched BRAFTOVI and MEKTOVI in Japan on February 26, 2019, to treat patients with unresectable melanoma with a BRAF mutation. This is another territory that should help boost revenue for the drugs. Lastly, a partner Pierre Fabre is seeking approval for the drug combo in Switzerland. Thus far, sales for the combo have not been that bad. It was reported that third-quarter sales for BRAFTOVI plus MEKTOVI came in at $35.1 million. This was a pretty good sized increase of 54% from the second quarter sales of $22.7 million. The main item to point out is that with the latest positive results for the BRAFTOVI triplet (BRAFTOVI, MEKTOVI, ERBITUX), the biotech can expand to the mCRC market for those patients with BRAF mutation. Besides expanding the market opportunity, there is another highly important item to highlight. The finding being that the BRAFTOVI triplet holds the potential to possibly be the very first chemotherapy-free targeted regimen for this patient population. Array not only holds the ability to possibly market the combination, but to allow patients to take a regimen that is free of chemotherapy. As you can imagine, that would be a major boost to a patient's quality of life not having to go through chemo. This could potentially become the first FDA approved treatment for BRAF-mutant mCRC. There are other treatments that are utilized to treat this type of cancer, but nothing specifically approved by the FDA for it. Array BioPharma is in good shape in terms of cash. It has approximately $479 million in cash, cash equivalents and marketable securities as of March 31, 2019.
Array BioPharma obtaining positive results for its phase 3 BEACON CRC study is good news for the company. It should be able to file for regulatory approval for its BRAFTOVI triplet by the second half of 2019. While this is very good news, there are several risk factors to consider. The first risk is that there is no guarantee that the FDA will approve the drug. It seems like safety and efficacy are in order for the triplet treatment, but unforeseen circumstances can change at the last minute for a regulatory application. Another risk would be the upcoming earnings report. Even though Array was able to grow its revenue from its fiscal second quarter to the third quarter, there is no guarantee that it will increase again in the coming quarter. Still, if the biotech receives approval for its BRAFTOVI triplet for BRAF-mutant mCRC that will help with revenue of both drugs for years to come. I believe Array remains a strong biotech for the long term as it continues to capitalize on its very robust pipeline.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.