Johnson & Johnson Seeks Drug Approval for Smoldering Myeloma Treatment
Johnson & Johnson is making waves in the medical community with their recent push for the first drug approval aimed at treating smoldering myeloma, a precursor to multiple myeloma. In the primary results of the randomized Phase 3 AQUILA trial, treatment with either daratumumab or J&J’s Darzalex alone showed promising outcomes for patients with high-risk smoldering myeloma.
The study, which randomized 390 smoldering myeloma patients to receive Darzalex or undergo active monitoring, revealed that patients who received Darzalex had a 51% reduced risk of disease progression or death after a median of 65.2 months. Additionally, progression-free survival at five years was significantly higher among patients who received the drug compared to those who did not. These results, published in the New England Journal of Medicine, have sparked excitement among experts and physicians in the field.
Debates and Challenges Surrounding Early Treatment for Smoldering Myeloma
Treating patients with smoldering myeloma has been a topic of contention among myeloma physicians for some time. The uncertainty regarding whether early treatment offers benefits to patients, as well as the challenge of identifying which smoldering patients will progress to active myeloma, has fueled these debates.
Hearn Jay Cho, the CMO of the Multiple Myeloma Research Foundation, expressed concerns about undertreating patients who are on the verge of developing multiple myeloma if a less aggressive therapy like Darzalex is administered. On the other hand, Irene Ghobrial, a myeloma physician and researcher at the Dana-Farber Cancer Institute, believes that the data support the use of Darzalex in some smoldering myeloma patients, highlighting the shift towards recognizing the benefits of early treatment.
GSK’s Blenrep Making a Comeback in Myeloma Treatment
GSK’s Blenrep, which initially received accelerated approval from the FDA in 2020 but faced setbacks in confirmatory studies, is now making a strong comeback in the realm of myeloma treatment. The combination treatment with Blenrep showed a significant reduction in the risk of death among patients with relapsed or refractory multiple myeloma in the DREAMM-7 trial.
Based on the interim data, GSK is optimistic about achieving a longer median overall survival period with Blenrep compared to the standard treatment. The company’s perseverance in continuing the development of Blenrep despite initial setbacks has positioned the drug for potential approval by the FDA next summer, with plans to explore its use in earlier lines of treatment as well.
