The following article features coverage from the 2021 Lymphoma, Leukemia & Myeloma Congress. Click here to read more of Hematology Advisor’s conference coverage.

Among patients with relapsed/refractory multiple myeloma (RRMM) with poor prognostic factors, a triplet regimen of melflufen, dexamethasone, and bortezomib appears to be well-tolerated, according to phase 1/2a trial data presented at the virtual 2021 Lymphoma, Leukemia & Myeloma (LL&M) Congress.

Resistance to treatment is a poor prognostic marker among patients with MM. Melflufen—a peptide-drug conjugate that targets aminopeptidases, releasing anticancer drugs in tumors—has previously shown efficacy in RRMM.

For this phase 1/2a dose escalation study (ClinicalTrials.gov Identifier: NCT03481556), researchers are evaluating the safety and efficacy of melflufen in combination with dexamethasone and bortezomib or daratumumab among patients with RRMM. In this poster, the researchers presented updates on initial results among patients who received the combination with bortezomib.


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Overall, data for 14 patients with RRMM were included. Seven patients received melflufen 30 mg and 7 received 40 mg; in these groups, the median ages were 76 and 70 years, respectively, 71% and 100% were male, and the median numbers of prior therapy lines were 3 and 2, respectively.

In the melflufen 30 mg group, the median follow-up was 6.1 months. At this point, the median number of treatment cycles was 7 (range, 1-32) and the median treatment duration was 6.1 months (range, 0.8-32.7). A total of 5 patients (71%) were receiving treatment at data cutoff, while 1 patient discontinued because of progressive disease. Thrombocytopenia and anemia led to dose reduction in 2 and 1 patients, respectively.

In the melflufen 40 mg group, the median follow-up was 15.1 months, at which point the median number of treatment cycles was 10 (range, 2-21) and the median treatment duration was 11.4 months (range, 2.1-23.9). A total of 3 patients (43%) were receiving treatment at data cutoff, while 2 patients, 1 patient, and 1 patient discontinued treatment because of an adverse event, progressive disease, or lack of efficacy, respectively.

In the 30 mg and 40 mg groups, the overall response rates were 57% and 71%, respectively, and the clinical benefit rate was 71% in both groups. Survival data were immature at data cutoff.

Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Read more of Hematology Advisor‘s coverage of LLM 2021 by visiting the conference page.

Reference

Hájek R, Pour L, Granell M, et al. ANCHOR (OP-104): melflufen plus dexamethasone and bortezomib in relapsed/refractory multiple myeloma—optimal dose, updated efficacy and safety results. Poster presented at: 2021 Lymphoma, Leukemia & Myeloma Congress; October 19-23, 2021. Abstract OP-104.