- Roche on Monday said its cancer drug Polivy combined with a common chemotherapy regimen held lymphoma in check for longer than the standard drugs alone in patients who had not been previously treated. According to the Swiss pharma, the drug is the first treatment shown to improve outcomes in these patients in 20 years.
- Polivy is currently approved for patients with an aggressive form of lymphoma after their disease has progressed following two prior treatments. The Food and Drug Administration gave its OK on a conditional basis after Roche reported tumor responses to treatment, and the placebo-controlled trial results announced Monday could be sufficient to merit full approval.
- Complete data from the POLARIX trial, which Roche says it will detail at an upcoming medical meeting, could also set a high benchmark for Gilead, Novartis and Bristol Myers Squibb as they seek to expand use of their CAR-T treatments in earlier lines of lymphoma treatment. Those cell-based therapies, while effective in improving survival in late-stage patients, have complicated, lengthy and expensive manufacturing processes.
Early treatment of diffuse large B cell lymphoma, or DLBCL, hasn't changed significantly since the introduction of Roche's Rituxan, which launched in 1998 and was quickly added to a chemotherapy regimen called CHOP in the early 2000s.
In later-stage disease, by comparison, the CAR-T treatments Kymriah from Novartis, Yescarta from Gilead and Breyanzi from Bristol Myers Squibb — all introduced since 2017 — were shown in studies to shrink tumors in patients who previously had few other options.
All three companies aim to move CAR-T into earlier lines of lymphoma treatment. Recent studies, for example, have found Yescarta and Breyanzi can extend progression-free survival for longer than high-dose chemo and stem cell transplantation among patients who had previously received one other treatment for their disease. And a small open-label study called ZUMA-12 showed promising response data for early treatment with Yescarta for high-risk large B-cell lymphoma.
Now, however, Roche is reporting first-line data for Polivy that show its easier-to-administer antibody can keep patients from progressing or dying for longer than R-CHOP.
According to Roche, about 40% of patients progress after receiving their initial therapy. The data from POLARIX show that Polivy "has the potential to be transformative" in delaying or reducing progression, Roche chief medical officer Levi Garraway said in a statement.
First approved in 2019, Polivy combines a synthetic antibody with a cancer-killing drug, allowing for targeted delivery of the drug to diseased cells without causing damage to healthy cells. Sales totaled 169 million Swiss francs, or about $184 million, in 2020.
Its "off-the-shelf" delivery could give it a competitive advantage should CAR-T treatments also be shown effective in delaying progression in first-line patients.
CAR-Ts require T cells to be extracted from patients, re-engineered to target diseased cells and then re-infused, a two-to-three week process that can only be performed at specialized centers. Producing the individualized treatments isn't always successful, and Novartis struggled in the first two years of Kymriah's launch to make the cellular product exactly within its approved specifications (although treatment could still be carried out.)
Side effects that often require urgent hospital treatment also mean patients treated with CAR-T aren't always allowed to return home once they have received their infusion.