Bristol-Myers to combo Opdivo, Yervoy with AbbVie's Rova-T in next-gen cancer cocktail trials

Bristol-Myers Squibb’s immunotherapy Opdivo has been powering ahead, racking up sales and new FDA approvals one after another. And with cancer-fighting immunotherapy cocktails seen as the next wave in oncology, the Big Pharma has teamed up with a range of companies to test Opdivo in combination with its partners’ meds.

Now, Opdivo has a new companion: AbbVie’s closely watched Rova-T, an antibody drug conjugate that targets cancer stem cells. Bristol-Myers and AbbVie plan to test Rova-T as an add-on to Opdivo, and to the Opdivo-plus-Yervoy pairing that recently won an FDA approval in melanoma.

The new trials will explore the two- and three-drug combos as treatments for non-small cell lung cancer, where Opdivo is already approved. The two companies are hoping that Opdivo, as a PD-1 checkpoint inhibitor, will complement Rova-T’s ability to target and kill cancer-initiating cells.

“By combining immune-checkpoint inhibitors that prime the body’s immune system to fight cancer cells with Rova-T’s approach to target cancer stem cells, we hope to build on our goal to develop differentiated treatments ... that elevate the standard of care for small cell lung cancer patients,” AbbVie VP Scott J. Dylla said in a Monday release.

Bristol-Myers has been striking combo drug deals in an effort to stay ahead in the immuno-therapy field, where it already competes head-to-head with Merck & Co.’s Keytruda in melanoma and lung cancer. Then there’s Roche’s Tecentriq (atezolizumab), which recently won an FDA nod to treat bladder cancer--an indication Opdivo also hopes to snare. Pipeline meds from Pfizer and AstraZeneca will also be looking to snag a piece of the PD-1/PD-L1 market.

AbbVie has a lot riding on Rova-T, too. The Illinois-based drugmaker paid $5.8 billion up front--plus $4 billion in potential milestones--for the drug’s developer, Stemcentrx, and execs bill Rova-T as a big contributor to sales after AbbVie’s megablockbuster drug Humira falls victim to biosimilar competition. It’s an expensive gamble, if not as expensive as AbbVie’s $21 billion purchase of Pharmacyclics and its share of the blood cancer med Imbruvica.

Analysts were disappointed in Rova-T data unveiled at the American Society of Clinical Oncology meeting last month. At the time, market-watchers saw more promise in lung cancer data from Bristol-Myers’ Opdivo-Yervoy combo. But the AbbVie drug did deliver good overall response rates in the Phase I trial presented at ASCO, and, as one of the trial researchers pointed out, the patients who responded most decisively also expressed the highest levels of DLL3, a protein that could prove a useful predictive biomarker in lung cancer.

Meanwhile, the Opdivo-Yervoy results rolled out at ASCO showed that 57% of lung cancer patients in the combo arm responded--a rate more than double the 28% Opdivo had previously posted on its own. That Phase Ib study focused on non-small cell lung cancer patients who hadn’t yet undergone chemo treatment and whose tumors expressed 1% PD-L1 or more.

For AbbVie, hitching to Opdivo’s wagon can’t hurt. With each new approval, Opdivo has racked up more impressive sales numbers. It brought in $942 million for Bristol-Myers in 2015, and it’s expected to hit $8.4 billion by 2020, according to EvaluatePharma.

- see the BMS-AbbVie release

Special Report: The top 20 drugs in 2020--worldwide sales - Opdivo

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