The retrospective analysis evaluated 17 patients with relapsed/refractory multiple myeloma (RRMM) treated in a real-world setting outside of clinical trials. Despite a highly refractory population—where 88% were triple-class refractory and 41% were penta-drug refractory—Pepaxti demonstrated a clinically meaningful overall response rate (ORR) of 41%.

Key Study Highlights:

• Strong efficacy in late-line settings: The ORR was 41%, with a median progression-free survival (mPFS) of 9.0 months in responding patients.
• Preserved access to future therapies: Notably, 100% of patients who received subsequent novel immunotherapies (such as CAR-T or bispecific antibodies) after Pepaxti achieved a partial response or better, with the majority reaching a very good partial response (VGPR) or better.
• Manageable safety in frail populations: The safety profile was consistent with previous clinical trials, despite a high portion (41%) of the cohort being >75 years old and many presented with reduced renal function.
• Strategic positioning: The data suggests Pepaxti serves as an effective "bridging" or interval therapy, maintaining disease control without compromising the success of subsequent T-cell redirecting treatments.

"Collectively, our data confirmed the efficacy previously reported with melflufen–dexamethasone and its manageable safety profile, also in elderly patients that likely are more fragile and more heavily pretreated than those included in the trials," says Dr. Elena Zamagni, Associate Professor at the University of Bologna, Italy, and lead author of the study. "Melflufen–dexamethasone may represent a treatment option, especially for patients refractory to novel immunotherapies or those who are not ideal candidates to receive such treatments while still preserving access to subsequent T-cell redirecting therapies".

"This independent real-world evidence from a leading European center is highly encouraging as we continue the commercial roll-out of Pepaxti in Italy and across Europe," says Stefan Norin, Chief Medical Officer at Oncopeptides. "The 100% response rate observed in subsequent immunotherapies is particularly significant for clinicians, as it addresses the critical question of treatment sequencing and confirms that Pepaxti can be used effectively to bridge patients to the next generation of care".
The full article, titled "Positioning of Melflufen in Heavily Pretreated RRMM Patients: Real-World Evidence in a Rapidly Evolving Therapeutic Landscape," is available online through this link.

For more information, including a Q&A for investors, please visit www.oncopeptides.com.