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Melflufen, dexamethasone demonstrate long-term OS benefits in multiple myeloma

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Paul G. Richardson

ORLANDO — Treatment with melflufen and dexamethasone led to sustained long-term overall survival among patients with relapsed/refractory multiple myeloma, according to a study presented at ASH Annual Meeting and Exposition.

“Although outcomes of patients have improved due to advances in therapy, multiple myeloma remains incurable and patients who relapse after conventional therapy have limited options for long-term disease control,” Paul G. Richardson, MD, clinical program leader and director of clinical research at Dana-Farber Cancer Institute’s Jerome Lipper Multiple Myeloma Center, told HemOnc Today.

In an updated analysis of the O-12-M1 study, Richardson and colleagues followed 45 patients with relapsed/refractory multiple myeloma (mean age, 66 years) for an additional 18 months to determine the longer-term OS and PFS outcomes of melflufen and dexamethasone treatment.

“Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells,” Richardson said.

Sixty percent of the patients had stage II or III disease at baseline. High-risk cytogenetics was present in 44% of participants.

Patients were previously treated with two or more lines of therapy (median, 4), including immunomodulatory drugs, proteasome inhibitors and alkylators, and had progressive disease within 60 days after the last therapy was completed. They received IV melflufen 40 mg on the first day of each treatment cycle, which lasted 28 days. They also received oral dexamethasone 40 mg each week for up to 8 cycles or longer depending on the investigator.

Follow-up was conducted over a median of 30.1 months. At the end of the study, the median PFS was 5.7 months (95% CI, 3.7-9.3; 98% events) and the median OS was 20.7 months (95% CI, 13.6-not reached; 58% events).

“Patients with stable disease as best response had a median overall survival of 47.2 months, suggesting sustained clinical benefit despite a limited depth of response,” Richardson said.

New adverse events were not observed.

“Melflufen plus dexamethasone is being further investigated in additional clinical trials including the pivotal phase 2 HORIZON study and the global, phase 3 OCEAN study,” Richardson said. – by Alaina Tedesco

Reference:

Bringhen S, et al. Abstract 1839. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2019; Orlando.

Disclosure: Richardson reports being a member of the Board of Directors or advisory committee for Amgen, Celgene, Jansen, Karyopharm, Oncopeptides, Sanofi and Takeda; and receiving research funding from Bristol-Myers Squibb, Celgene, Oncopeptides and Takeda.