Roche sets bar in early lymphoma treatment with Polivy study results

SWITZERLAND – Swiss pharmaceutical giant, Roche, has said its cancer drug Polivy combined with a common chemotherapy regimen holds lymphoma in check for longer than the standard drugs, in patients who have not been previously treated.

According to Roche, the drug is the first treatment shown to improve outcomes in such 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.

Lymphoma is a cancer of the lymphatic system, which is part of the body’s germ-fighting network. The lymphatic system includes the lymph nodes (lymph glands), spleen, thymus gland and bone marrow. Lymphoma can affect all those areas as well as other organs throughout the body.

The two main kinds of lymphoma are Hodgkin lymphoma, which spreads in an orderly manner from one group of lymph nodes to another, and Non-Hodgkin lymphoma (NHL), which spreads through the lymphatic system in a non-orderly manner.

According to the American Cancer Society’s estimates, about 81,560 people (45,630 males and 35,930 females) will be diagnosed with NHL. This includes both adults and children. About 20,720 people will die from this cancer (12,170 males and 8,550 females) in 2021.

Fortune Business Insight has valued the global lymphoma treatment market at US$6.94 billion and is projected to reach US$13.11 billion by 2026, exhibiting a CAGR of 8.3% during the forecast period.

The Food and Drug Administration approved Polivy 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.

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 US$184 million, in 2020.

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, have shown to shrink tumors in patients who previously had few other options.

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