Roche’s Polivy gets FDA okay for lymphoma chemo-immunotherapy

The FDA has approved Roche’s Polivy as part of the first chemo-immunotherapy combination for a B-cell lymphoma.

The antibody-drug conjugate has been cleared for use alongside the chemotherapy bendamustine and Roche’s blockbuster immunotherapy Rituxan (rituximab) as a regimen for adults with diffuse large B-cell lymphoma (DLBCL) who have previously been treated with at least two prior therapies.

Polivy (polatuzumab vedotin) is a first-in-class ADC that targets CD79b, a protein found only on B cells, and releases a cytotoxic payload to kill the cells, and had been given both FDA breakthrough and EU PRIME designations because of the lack of effective therapies for these patients.

The FDA approval comes in earlier than expected given that the FDA only started its priority review of the application in February, and is based on the results of a phase 1b/2 study in 80 patients with DLBCL who were not eligible for a bone marrow transplant and were assigned to receive Polivy plus bendamustine/Rituxan or bendamustine/Rituxan alone.

There was a 40% complete response rate with the triple regimen, compared to 18% in the control group, accompanied by an increase in overall survival to 11.8 months from 4.7 months, even though the trial wasn’t powered to show a survival benefit.

That is viewed as an impressive response as the prognosis for transplant-ineligible, relapsed or refractory DLBCL patients is notoriously poor, and is the first randomised study to show an overall survival advantage in this setting.

“Despite meaningful progress in the treatment of DLBCL, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Sandra Horning, Roche’s chief medical officer.

“Today's approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”

Roche is also looking at combining Polivy with its CD20/CD3 bispecific antibody mosunetuzumab in DLBCL and follicular lymphoma, and moving the ADC into earlier lines of therapy.

Polivy is one of two new cancer approvals Roche is anticipating this year along with entrectinib for NTRK fusion-positive solid tumours, a rival to Bayer/Loxo’s recently-approved Vitrakvi (larotrectinib).

The roll-out of new cancer therapies comes as Roche is feeling the first hit of biosimilar competition to its established trio of blockbuster antibodies, which along with Rituxan also includes Herceptin (trastuzumab) and Avastin (bevacizumab).

This year should also see filings for anti-IL-6 antibody satralizumab for neuromyelitis optica and for risdiplam, a small-molecule gene splicing modifier for rare disease spinal muscular atrophy (SMA), setting up potential approvals in 2020.