Johnson & Johnson (J&J) today revealed ground-breaking positive topline results from the investigational Phase 3 MajesTEC-3 study. These results showed that a combination regimen of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and TECVAYLI® (teclistamab-cqyv) significantly improved overall survival (OS) and progression-free survival (PFS) when compared to standard-of-care treatments.
In patients with relapsed/refractory multiple myeloma (RRMM) who had previously received one to three lines of therapy, the MajesTEC-3 study assessed the safety and effectiveness of the TECVAYLI and DARZALEX FASPRO combination in comparison to the investigators’ standard regimens (DARZALEX FASPRO with either pomalidomide and dexamethasone or bortezomib and dexamethasone).
Statistically Significant Improvements in Survival
The primary endpoint of progression-free survival (PFS), which measures how long a patient’s cancer is under control before progress or death is reached, was reached at nearly three years of follow-up. The outcomes outperformed the standard-of-care treatments and were statistically significant.
Importantly, this initial interim analysis also revealed that overall survival (OS), the secondary endpoint, was statistically significant. The Independent Data Monitoring Committee (IDMC) suggested unblinding the study in light of these compelling findings.
By simultaneously targeting BCMA and CD38, the combination utilizes two distinct yet complementary mechanisms of action to prime and activate the immune system, thereby eradicating myeloma cells.
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Key Takeaways
- Phase 3 MajesTEC-3 study.
- Relapsed/refractory multiple myeloma (RRMM) patients who have had one to three previous lines of treatment make up the patient population.
- The main finding was that, in comparison to standard care, the combination of TECVAYLI and DARZALEX FASPRO significantly increased Progression-Free Survival (PFS).
- Secondary Finding: When compared to standard of care, the combination greatly increased overall survival (OS).
- Significance: This combination is the first Phase 3 study to demonstrate superior PFS and OS, suggesting a possible new standard of care.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
