J&J and Genentech partnering in two cancer studies combining Darzalex with atezo
- Johnson & Johnson plans to study its multiple myeloma drug Darzalex (daratumumab) in combination with Genentech's anti-PDL1 atezolizumab, said Janssen, a unit of J&J. Janssen will sponsor a Phase 1b study of solid tumors while Genentech will amend a separate Phase 1b study to investigate the combination against refractory multiple myeloma.
- By teaming up with multiple partners to test its PD-1 checkpoint inhibitor, atezolizumab, Genentech (a division of Roche) is attempting to broaden therapeutic potential to treatment of solid tumors.
- Genentech's clinical development program for atezolizumab is exceedingly ambitious. In 2015, there were more than 30 clinical trials underway, including 11 phase 3 trials. The goal is to test atezolizumab in combo with various immunotherapies in order to address not only hematologic cancers but also with solid tumors, where there are currently no indications.
For J&J, this is the first time that Darzalex is being tested for treatment of a solid tumor. The FDA approved the monoclonal antibody drug in November 2015 for treatment of multiple myeloma in patients who have received three prior lines of therapy.
Roche has been pushing immunotherapy collaborations recently. Last week, Roche's Genentech teamed up with Kite Pharma to test atezolizumab with Kite's CAR-T therapy. The companies plan to launch a Phase 1b/2 study later this year. Roche is also testing the drug as part of combination therapy with another immunotherapy drug (from Amgen) for treatment of triple-negative breast cancer and colorectal cancer with liver metastases.
Atezolizumab was recently granted priority review itself, with a target FDA action date of September 12,2016.
Both Darzalex, which J&J licensed from Denmark-based Genmab in 2012, and atezolizumab are expected to reach blockbuster status in the next five years.