Real-world Study Supports Blenrep for Hard-to-treat RRMM

Blenrep's effects in real-world setting found to be similar to those in clinical trials

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The efficacy and safety of Blenrep (belantamab mafodotin) as a treatment for relapsed/refractory multiple myeloma (RRMM) in a real-world setting is similar to what has been reported in clinical trials, according to a study from Israel.

“Response rate, duration of response and toxicity profile appear to be comparable to those observed in prospective trial settings. … These findings support the role of [Blenrep] as a beneficial treatment option for heavily pretreated RRMM patients,” researchers wrote.

The study, “Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study,” was published in the British Journal of Haematology.

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Blenrep approved to treat people with hard-to-treat RRMM

Blenrep is approved to treat people with RRMM who have failed to respond to multiple prior lines of therapy in the U.S. and in Europe. The therapy works by targeting BCMA, a protein commonly found on the surface of myeloma cells.

The approvals were supported by data from the open-label DREAMM2 clinical trial (NCT03525678), which tested the therapy in nearly 200 heavily pretreated RRMM patients. Clinically meaningful responses were reported in about a third of the participants in the trial.

Although clinical trials are considered the gold standard for testing whether a medication works, results in these carefully controlled studies are not always reflective of outcomes in real-world clinical practice.

Therefore, a team of scientists in Israel set out to report on outcomes for RRMM patients who were treated with Blenrep in real-world practice through a compassionate use program funded by the therapy’s developer GSK. The company was not directly involved in this study, though one of the authors disclosed having received unrelated honoraria from GSK for other projects.

“In this study, we aimed to analyse real-world outcomes of [Blenrep] therapy among a multisite Israeli cohort treated with [Blenrep] via the GSK compassionate access programme, and to assess whether clinical trial results are compatible with outcomes in the real-world setting,” the researchers wrote.

Response rate, duration of response and toxicity profile appear to be comparable to those observed in prospective trial settings

The study included 106 RRMM patients treated with Blenrep between 2019 and 2021. Just over half of the patients were male, the median age was 69.4 years, and patients had received a median of six prior lines of myeloma treatment.

“To the best of our knowledge, this is the largest [Blenrep] real-world series reported to date,” the scientists noted.

The overall response rate, based on 101 evaluable patients, was 45.5%. This rate was similar regardless of initial Blenrep dose (2.5 or 3.4 mg/kg). Specifically, 4% had a complete response (no detectable cancer) and the rest had a partial response, meaning cancer burden decreased but myeloma was still detectable.

Among participants who responded to treatment, the median duration of response was 8.1 months, and median time without disease progression was 8.8 months.

Among all 106 patients, the median overall survival time was 14.5 months, and survival outcomes were significantly better for patients who responded to treatment: among non-responders, the median survival time was 7.1 months, whereas for responders, the median survival time was not reached (meaning most patients were still alive at the time of data cut-off).

Overall, these response rate and survival outcomes are “comparable to the results published for … the DREAMM2 study,” the researchers wrote.

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Safety data in real-world study similar to findings in DREAMM2 trial

Safety data in this real-world study also were similar to what was reported in DREAMM2. More than two-thirds of evaluable patients experienced keratopathy (damage to the front of the eye), which was severe in nearly half of these patients. Blurred vision was reported by 36.8% of patients, and was often associated with keratopathy, though in most cases vision impairment was not rated as severe.

The researchers noted that keratopathy and blurred vision were reversible after stopping Blenrep for most patients.

Non-eye-related safety findings included reduced counts of blood cells and platelets, infections, and allergic reactions. Most of these events were not rated severe, though there were two cases of death related to infection.

“Infectious complications were not uncommon, highlighting the need for close surveillance and early intervention as needed,” the researchers wrote.

There also were two reported cases of tumor lysis syndrome — a life-threatening inflammatory condition that can develop when many cancer cells die in the body at the same time — which has not been reported in prior trials of Blenrep. This finding highlights “the need for risk assessment and appropriate prophylactic [preventive] and supportive measures in high-risk patients,” the researchers said.