AbbVie, Bristol-Myers to combine checkpoint inhibitors, Rova-T in cancer trials

Bristol-Myers Squibb ($BMY) will team up with AbbVie ($ABBV) to run an early-stage lung cancer study combining BMS’ marketed checkpoint inhibitors with AbbVie’s experimental antibody drug conjugate Rova-T.

The Phase I/II study, slated to start later this year, will see Bristol bring its immunotherapies Yervoy (ipilimumab) and Opdivo (nivolumab) to the table--two drugs that have helped shape a new approach to treating cancer.

The treatments, which have blockbuster sales and between them licenses for melanoma and non-small lung cancer among others, will be used together with AbbVie’s Rova-T (rovalpituuzumab tesirine) for relapsed extensive-stage small cell lung cancer (SCLC). One study will also look at just Opdivo and Rova-T.

We already know of the immunotherapy effect from BMS’ meds, drugs that essentially “take the brakes off” the immune system and enable it to fight cancer, but this tie-up is designed to assess whether AbbVie’s med--which works as a targeted cell killing and antigen release--can further enhance the effect of immunotherapy from Yervoy and/or Opdivo.

Rova-T targets cancer stem cells and combines a targeted antibody that delivers a cytotoxic agent directly to cancer cells expressing a delta-like protein 3 (DLL3)--which is expressed in more than 80% of SCLC tumors.

The drug is undergoing third-line trials for the treatment for SCLC, although it is also planning first-line tests, as well as studies into other tumors, in the coming years.

Data out in June showed some positive results for the drug on its own, coming after the U.S. giant pay $5.8 billion upfront--with $4 billion reserved for milestones--for Stemcentrx and its Rova-T.

But the overall data in SCLC failed to win favor with many analysts, especially given the price tag paid for access to the drug and the modest survival benefit it produced.

Still, most Big Pharmas and biotech are now combining new therapies--especially cancer immunotherapies--with other drugs based on the theory that many hands make light work of cancer.

“We believe the combination of these cancer-fighting agents may offer patients a new treatment option in a disease with limited therapies,” said Scott J. Dylla, VP of research and development at AbbVie.

“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 with therapeutic benefit that elevate the standard of care for small cell lung cancer patients.”

This comes as AbbVie has been ramping up the oncology deals in recent months, with three cancer deals signed in April alone as it looks to shore up its early-stage pipeline in the wake of an oncoming onslaught of its $14 billion a year Humira (adalimumab) in the form of a slew of biosimilars. The company will hope to help produce revenue from its R&D machine, with a focus on cancer, once sales from the autoimmune drug are decimated over the next 5-10 years. 

Although not as prevalent as non-small cell lung cancer, SCLC is still responsible for around 15% of all lung cancers, and has a poor survival rate with no targeted treatments.

- check out the release

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