GSK’s BLENREP has become the first anti-BCMA therapy to secure a position in the treatment algorithm of multiple myeloma (relapsed or refractory setting).
This approval was a highly anticipated event and significant for the multiple myeloma treatment landscape because it helps address an important unmet need for patients who have received at least four prior therapies with limited therapeutic options remaining (particularly patients who are refractory or relapsed to Darzalex-containing regimens). This ADC (antibody drug conjugate) holds distinct advantages as an off-the-shelf therapy overcoming the complex manufacturing process primarily associated with the emerging anti-BCMA CAR T-cell therapies.
Here we provide an overview of the recent regulatory approval and our view on what’s ahead for the market.
GSK’s anti-BCMA ADC BLENREP reaches the finish-line
- The FDA and EC approval of BLENREP, makes it the first-in-class anti-BCMA therapy approved for relapsed / refractory (R/R) multiple myeloma patients, ahead of Bristol Myers Squibb / bluebird bio’s anti-BCMA CAR T-cell therapy idelcabtagene vicleucel (ide-cel) and J&J’s anti-BCMA CAR T-cell therapy JNJ-68284528.
- BLENREP was awarded FDA and EC approvals based on positive results reported from a Phase II study (DREAMM-2) and has been approved for patients who have received at least four previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
- Competition is fierce in this space; Bristol Myers Squibb / bluebird bio’s anti-BCMA CAR T-cell therapy ide-cel is also being evaluated at various doses in a Phase II study (KarMMa) for the same patient population, and JNJ-68284528 is under investigation in the Phase Ib/II CARTITUDE-1 trial.
“If a patient is being treated with a BCMA-based therapy in the future, it would be with the ADC and that will be in combination with other agents like an immuno-modulating drug and a proteasome inhibitor; this combination would be certainly feasible.”
— Hematologist-oncologist, United States
“In terms of convenience, the ADC therapy is much easier to use as compared with CAR T-cells where the treatment needs to be customized for individual patients, and involves a lengthy and complicated procedure.”
What does this approval tell us and what should other competitors in this dynamic space expect?
BCMA targeted agents demonstrate impressive efficacy in heavily pre-treated multiple myeloma patients
- BLENREP and the CAR T-cell therapy ide-cel have shown durable responses to date. However, response rates (ORR and CR) and progression-free survival (PFS) for ide-cel have been markedly higher than those of BLENREP in the KarMMa and DREAMM-2 studies, respectively.
Safety, production time, patient quality of life, physician familiarity, and pricing are all likely to be critical differentiators for success
- Reported adverse events, anticipated cost of treatment, and factors associated with time and processes in manufacturing will influence physician and payer decisions on prescribing and reimbursement for the preferred anti-BCMA therapy.
- The ease of manufacturing process and administration offered by BLENREP make it an off-shelf product unlike the autologous CAR T-cell therapies; this may provide the ADC with logistical advantages going forward.
Competition set to intensify in the already saturated R/R setting
- Following the FDA and EC approvals of GSK’s BLENREP in fourth-and later treatment lines, the ADC stays ahead of its CAR T-cell competitors ide-cel and JNJ-68284528; the ADC is set to dominate the later-lines of therapy, influenced by efficacy data, manufacturing process and mode / ease of administration.
- We anticipate the BCMA-targeted therapies to achieve major-market sales of over $1 billion in the R/R setting in 2028, and we expect BLENREP to be one of the major contributors towards this growth.