Elranatamab (ELEREXFIO) Trial Updates | Bryan Husbeck | EHA 2024

Hi, my name is Brian Husbeck. I am Global Hema Oncology Medical Head at Pfizer. I'm here to briefly summarize some of our latest clinical findings for L-Renatumab, our BCMA-directed bispecific antibody, which were presented here at EHA 2024. L-Renatumab received accelerated approval by the FDA last August for the treatment of relapsed refractory multiple myeloma after four prior lines of therapy. The approval of L-Renatumab is based on the overall response rate and the duration of response observed in the single-arm phase II magnetism III study. 58% of patients achieved an objective response, with the majority of those responses being a very good partial response or better. After a median follow-up of 11 months, the median duration of response had not been reached, and the likelihood of maintaining a response in nine months was 82.3%. The data demonstrated that heavily pretreated patients with relapsed or refractory multiple myeloma experienced durable responses when treated with L-Renatumab. Continued approval is contingent upon verification of clinical benefit in a confirmatory trial. It fills my colleagues and me with immense joy to contribute to this innovative phase of T-cell redirecting therapies, which have been transformative in the management of multiple myeloma, marking a significant milestone in patient care. We are delivering over 10 presentations at EHA 2024, which collectively adds to the compelling evidence that supports L-Renatumab as an important treatment option for patients with advanced relapsed and refractory disease. In the next few minutes, I'd like to highlight three of those presentations. The first is the long-term survival update from our pivotal Phase II Magnetism III single-arm study, which evaluates L-Renatumab monotherapy in patients with triple class exposed multiple myeloma. This update will focus on the subset of 123 heavily pretreated patients who have not been previously treated with BCMA targeted therapies. This update shows that after two years, patients treated with L-Renatumab had an OR of 61% and a median overall survival of 24.6 months. Additionally, the median progression-free survival was 17.2 months, and the median duration of response was not reached. This extended follow-up shows sustained clinical efficacy and no new safety signals. We continue to explore optimal management and prevention of CRS, neurotoxicity, and infections in the real-world settings, which are commonly associated with BCMA-directed therapies. Pfizer continues to advance the Magnetism clinical development program by investigating L-Renatumab's use across the entire spectrum of myeloma progression. This includes its use from the initial diagnosis to stages of relapse and refractory multiple myeloma, evaluating its effectiveness both as a single-agent therapy and in combination with standard or novel therapies. This leads to the next two abstracts I'd like to highlight. Magnetism 32 is a Phase III study evaluating L-Renatumab alone versus other standard treatment combinations in patients with second-line or later relapse refractory multiple myeloma to assess if L-Renatumab offers more clinical benefit. The main goals of the Magnetism 32 study are to measure how long patients can live without their disease getting worse and to measure overall survival. This study may be an option for individuals who are 18 years of older, have multiple myeloma, that has come back after prior treatment, including prior treatment with an anti-CD38 antibody and lenalidomide. The next study, Magnetism 30, is set to evaluate a promising new treatment strategy for multiple myeloma. This involves the use of L-Renatumab in combination with a novel class of drugs known as Cereblon E3 ligase modulators, or cell mods, which are currently under clinical research. Specifically, this Phase Ib study will investigate the combination of L-Renatumab and Neburdimide, a cell mod, in clinical development for patients with relapsed or refractory multiple myeloma. The study aims to investigate whether this combination can improve the depth and durability of response in patients with relapsed or refractory multiple myeloma. This research represents a significant step in the ongoing efforts to improve therapeutic options for multiple myeloma patients. Both clinical trials are currently active and accepting patients. To improve the lives of patients, the objective of our development program is to discover effective treatments to enhance the lives of individuals with multiple myeloma. More information on the Magnetism clinical development program can be found on PfizerClinicalTrials.com. Patients and their care partners can read more about all of our EHA 2024 presentations through Pfizer's Abstract Plain Language Summaries, or APLS. APLS serve to make the emerging research findings presented at medical conferences more straightforward and accessible to anyone seeking such information. APLS for all EHA presentations can be found online at Pfizer.com. APLS for up to two weeks following the Congress and will also be accessible via the QR code available at Pfizer booths. Thank you.