Genentech and Johnson & Johnson ($JNJ) are joining hands on another checkpoint combo program, matching Darzalex (daratumumab) and the PD-L1 drug atezolizumab for an unidentified solid tumor as well as multiple myeloma, where Darzalex is already approved for use.
J&J will take the lead on a Phase Ib combination study for a solid tumor, while Genentech will be in charge of the multiple myeloma program, which is already in the clinic.
Roche's ($RHHBY) atezo has lined up as the first likely approval for the PD-L1 (programmed death ligand-1) side of the checkpoint equation for cancer, following breakthrough approvals for Merck's ($MRK) Keytruda as well as Bristol-Myers Squibb's ($BMY) leading drug Opdivo, both PD-1 drugs. The class has demonstrated a distinct ability to dismantle a cloaking device cancer cells use to escape detection by the immune system, opening up a broad based assault that can be easily matched with more targeted therapies.
The industry has followed up with dozens of combination development programs, and J&J and the big Roche subsidiary will now take their place in a very long line. At one point last year Roche had three dozen ongoing trials for atezolizumab, including 11 Phase III studies. All the leaders, including a more distant fourth-place rival at AstraZeneca ($AZN), have been pouring in money and resources in an effort to identify and capture key market segments in the oncology field.
Just days ago Roche and Kite ($KITE) unveiled plans to combine atezo with a leading CAR-T therapy, which engineers T cells into attack vehicles. That closely followed the FDA's decision to grant atezo--already named a "breakthrough" therapy--a priority review for bladder cancer. And Pfizer ($PFE)/Merck KGaA have been ramping up their combo plans in the checkpoint field as well, recently allying itself with Verastem's failed therapy.
The partnership news today is also good for Genmab, which outlicensed the CD38 antibody Darzalex to J&J. Darzalex was approved last fall to treat multiple myeloma.
"We are very excited about the start of the first study to investigate daratumumab in a solid tumor, potentially expanding its clinical utility beyond hematological cancers," said Jan van de Winkel, chief executive officer of Genmab, in a statement. "We are equally excited about testing daratumumab in combination with an immune checkpoint inhibitor, such as Roche's anti-PDL1, atezolizumab, in multiple myeloma. Both studies mark a key next step in the expansive clinical development of daratumumab in the hope to find even more effective treatment options for cancer patients."
- here's the release