What happened
In response to sharing clinical data at a medical conference over the weekend, shares of Array BioPharma (ARRY +0.00%), a clinical-stage biotech focused on cancer, jumped 17% as of 11:25 a.m. EST on Monday.
So what
Array and its partner Pierre Fabre shared data from their phase 3 BEACON CRC trial at the ASCO 2018 Gastrointestinal Cancers Symposium on Saturday. This study is evaluating a triplet combination of encorafenib, binimetinib, and cetuximab as a treatment for colorectal cancer. Eencorafenib and binimetinib are both co-owned by Array and Pierre Fabre.
Here's an overview of the findings of the 30 patient study:
- The estimated median progression-free survival at the time of analysis was eight months.
- The confirmed overall response rate (ORR) was 48%. What's more, the ORR was 62% in the 16 patients who received only one prior line of therapy.
- Three patients achieved complete responses.
- The combination was generally well-tolerated, though two patients did discontinue treatment due to adverse events. However, only one of these events was considered to be related to the treatment.
Dr. Scorr Kopetz, a physician at the University of Texas MD Anderson Cancer Center, helped put this data into context:
The observed median progression-free survival of eight months exceeds historical benchmarks of approximately two months for median progression-free survival, and four to six months for median overall survival, with current standards of care in this patient population. These results demonstrate the potential of the triplet combination to benefit this population of patients who currently have very limited effective treatment options.
Given the clinical update, it is easy to understand why traders are feeling giddy today.
Image source: Getty Images.
Now what
2018 is poised to be a transformative year for Array. Both binimetinib and encorafenib are currently pending regulatory review in the U.S. and Europe as a treatment for BRAF-mutant metastatic melanoma. A PDUFA date of June 30, 2018 has been set, so it won't be long before shareholders have a go/no-go decision in hand.
What are the odds of success? That's tough to say, but my hunch is that the company's chances are favorable since the COLUMBUS study showed that using these drugs lead to enhanced progression-free survival rates when compared to Roche's current top-selling treatment Zelboraf. Adding in this recent data from the BEACON CRC trial should give investors increased confidence that these drugs are the real deal.
All in all, Array's shareholders have plenty of reason to remain excited about binimetinib and encorafenib, not to mention the rest of the company's pipeline. However, there's an argument to be made that Array's current market cap of $3 billion is already pricing in the green light from regulators. That's why this Fool plans to root for Array's success from the sidelines.
