- AbbVie will test its experimental lung cancer drug Rova-T in combination with two immunotherapies from Bristol-Myers Squibb in an early-stage trial in small cell lung cancer (SCLC), the companies said Monday.
- Rova-T is one of AbbVie's big bets in oncology, picked up in the $5.8 billion acquisition of Stemcentrx earlier this year. But the drug has failed to wow investors so far, posting promising but unspectacular results from an early study presented at the annual meeting of the American Society of Clinical Oncology in June.
- The companies will test a combination of Rova-T and Bristol-Myers soon to be blockbuster checkpoint inhibitor Opdivo, as well as a triple combo of Rova-T, Opdivo, and an earlier immunotherapy called Yervoy.
Opdivo has been the drug for choice for many combination trials in oncology, given its ability to boost the immune system's response to tumors. Similar to Merck's rival Keytruda, Opdivo works by blocking a protein called PD-1, which functions as a "checkpoint molecule" and suppresses an immune response to tumor cells. By disrupting that signaling, Opdivo helps boost the ability of T-cells to target and kill cancers in some patients.
Rova-T, on the other hand, is an antibody drug conjugate, a powerful combination of a targeted antibody with a cytotoxic warhead. The drug looks for a specific protein—a delta-like protein 3 (DLL3) —commonly expressed in more than 80% of SCLC patient tumors, but not on healthy adult cells.
AbbVie hopes combining Rova-T with Opdivo will enhance the effect of both drugs.
“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," said Scott J. Dylla, vice president of R&D at AbbVie.
The companies will study the drug combinations in a Phase 1/2 study of patients with SCLC, a particularly deadly type of lung cancer which affects roughly 15% of all lung cancer patients.
AbbVie also indicated it has near-term plans to study Rova-T as a first-line treatment for SCLC. A Phase 2 study looking at Rova-T as a third-line option is expected to read out sometime next year and Abbvie hopes to launch the drug in 2018 through accelerated approval, if all goes well.
But the drug will likely need to show better results than the data unveiled at ASCO to truly excite investors.