GSK poised to leap back into the oncology market with more positive belantamab mafodotin results — but BCMA rivals are swarming in behind
GlaxoSmithKline took an important step toward a key new approval Monday night, posting their second positive round of pivotal data for the BCMA-targeting multiple myeloma conjugate belantamab mafodotin (GSK2857916). And with upbeat DREAMM-2 data, they’ve filed for an approval with hopes of getting a priority review for their “breakthrough” drug candidate.
But after the stellar rounds of new data in the BCMA field at ASH a few days ago, don’t expect a tremendous level of excitement to greet them over the outcome.
To be sure, a 31% overall response rate among 97 very sick patients with 3 complete responses in the bunch is likely enough to warrant an FDA OK — given regulators’ track record when it comes to patients and options. But the results leave open the question of what the long-term commercial prospects can be as GSK makes its way back into the oncology market after a long and painful absence.
Median duration has not been established yet.
For ‘7916, the new data batch marks a significant drop from the 60% ORR in DREAMM-1, though investigators note that this new trial included a much sicker set of patients with dwindling options. At ASH we also saw a CAR-T from J&J that delivered a 100% response rate in the BCMA field for multiple myeloma. That came with a jaw dropping 69% complete response rate. Regeneron impressed with its bispecific REGN5458, while bluebird and Bristol-Myers Squibb lead the booming BCMA field, and now add their bispecific CC-92369 to the list of ambitious candidates. The list goes on.
And out in front, Darzalex continues to make new progress in combination with other drugs for multiple myeloma. At ASH Amgen posted a 37% reduction in the risk of progression of multiple myeloma for patients treated with a combination of Kyprolis and the blockbuster Darzalex from J&J and Genmab, compared to either alone.
Game over for GSK?
Axel Hoos, the GSK oncology R&D chief who kept the flame of early-stage cancer R&D burning after a big pipeline/commercial swap with Novartis, readily agrees that both the CAR-Ts as well as the bispecifics have a lot of exciting data behind them. They also have further to go in the clinic, he adds, and in CAR-T’s case, serious cytokine release syndrome safety issues as well as a continuing set of manufacturing obstacles that continues to drag back the pioneers.
Move back to a conjugate like theirs, Hoos says, and there are real advantages in scalability and access that gives GSK a real shot at making a mark in the field — soon.
“We think we have a more potent agent and that should play out as you start combining,” he adds, important in a field where combinations are king. In the meantime, everything from DREAMM-3 to DREAMM-10 are in the works, underscoring a commitment to amp up their commitment to drugs that have potential.
Armed with a breakthrough therapeutic designation at the FDA, and PRIME from the EMA, it’s likely that GSK won’t have to wait much longer before it starts to put its toe back in the cancer drug market. And with Luke Miels leading the commercial charge following the Tesaro PARP buyout, everyone at GSK knows they have a lot to prove as R&D chief Hal Barron and CEO Emma Walmsley take new steps to prove they’ve revived a stagnant pharma R&D group.
Here we go.