Three years after its initial FDA approval, Roche has made up for an early disadvantage with its blood cancer drug Lunsumio amid competition among CD20xCD3 bispecific antibodies.
The FDA has approved Lunsumio Velo as a subcutaneous formulation for the treatment of follicular lymphoma after two or more lines of systemic therapy, Roche’s Genentech unit said Monday.
Lunsumio was the first anti-CD20 bispecific approved by the FDA with a go-ahead in December 2022 to treat third-line follicular lymphoma. As an off-the-shelf intravenous infusion, Lunsumio boasts a convenience edge over individualized CAR-T therapies.
But that advantage was soon lost to AbbVie and Genmab’s rival T-cell engager Epkinly, which started off as a subcutaneous injection with an initial nod in third-line diffuse large B-cell lymphoma (DLBCL), followed by a June 2024 green light to enter follicular lymphoma.
Now, Lunsumio Velo is allowing Roche to fill that gap of administration convenience; all the while, the company has been touting its fixed-duration regimen, which allows patients to stop treatment after a few cycles; Epkinly is given indefinitely until disease progression or unacceptable toxicity.
The new under-the-skin formulation reduces the Lunsumio administration time to about one minute compared with two to four hours for an infusion, depending on the treatment cycle, according to Roche.
“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” Roche’s head of global product development and chief medical officer, Levi Garraway, M.D., Ph.D., said in a Dec. 22 statement. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”
The latest approval is based on data from the phase 1/2 GO29781 trial, which showed the two formulations lead to similar concentrations in the blood. Lunsumio Velo also demonstrated an objective response rate of 75% and a complete response rate of 59%. The median duration of response was 22.4 months.
As Lunsumio’s original nod is still an accelerated approval, so is the current nod for the subcutaneous version. Roche is testing the drug alongside lenalidomide (Bristol Myers Squibb’s Revlimid) in the phase 3 MorningLyte study in previously untreated follicular lymphoma.
Making intravenous infusions into subcutaneous injections has become a popular strategy among drugmakers. Roche itself got FDA approvals last year for subcutaneous versions of its PD-L1 cancer drug Tecentriq and popular multiple sclerosis treatment Ocrevus. More recently, Merck & Co.’s subcutaneous Keytruda and Johnson & Johnson’s EGFR lung cancer med Rybrevant Faspro also gained the FDA’s blessing.
Drugmakers should break from the habit of going to intravenous first and start thinking about subcutaneous development from the get-go, Helen Torley, CEO of the drug delivery specialist Halozyme, said at the Fierce Biotech Week 2025 conference in October.
To do that, drug developers need to get familiar with the early pharmacokinetic profile of subcutaneous drugs and build an understanding of how that can be translated into the kind of data needed to pick the dose in later-stage clinical trials, Torley said.
At least Roche has already been using the subcutaneous version in other Lunsumio studies, including MorningLyte and Sunmo, which recently reported that Lunsumio’s combination with Roche’s Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in second-line LBCL patients who are not eligible for transplant.
Roche’s other CD20xCD3 drug, Columvi, recently hit a setback, as the FDA declined to approve it in combination with chemotherapy for the treatment of second-line, transplant-ineligible DLBCL because of unconvincing data in U.S. patients.
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