Roche is counting on newer drugs to help it weather brutal attacks from biosimilars to its cancer troika. Now, the Swiss pharma is seeing a potential blockbuster opportunity down the line with Polivy that could help counter the losses seen for Rituxan, Herceptin and Avastin.
A key data readout for Polivy is expected in “weeks,” Roche’s pharma chief Bill Anderson told investors during a conference call Thursday. If successful, the antibody-drug conjugate could be approved for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The indication’s sales potential? Up to $2 billion worldwide, Anderson said.
With an FDA nod mid-2019, Polivy is currently allowed to treat DLBCL patients after at least two prior therapies, a field that Anderson said has “limited growth potential.” Indeed, in the first six months of 2021, the drug only pulled in sales of CHF 94 million ($103 million) after a 17% year-over-year growth.
“We think really the big potential for Polivy is in the context of first-line DLBCL. The potential worldwide is up to CHF 2 billion in sales; this is the biggest lymphoma indication,” he said.
The phase 3 newly diagnosed DLBCL trial, dubbed Polarix, pits a combination of Polivy with Roche's own Rituxan and a triplet chemotherapy called CHP against the standard-of-care treatment, R-CHOP, which couples Rituxan with a chemotherapy regimen.
The indication is so important that Anderson said it could “determine the future” for Polivy. And if successful, it could be the first major positive readout in front-line DLBCL in 17 years, he noted.
With a positive study, adoption of Polivy could be high because front-line DLBCL is a curative setting, Anderson said. “Even a few percentage points increase in the cure rate would be an important level of improvement,” he added.
As Citi analyst Andrew Baum observed during the call, there’s a “very strong desire” to adopt Polivy among community physicians if it proves to be efficacious. Currently, these doctors have to transfer high-risk patients to higher-level tertiary care centers; but Polivy, with potentially a better safety and tolerability profile, could allow community doctors to keep these patients and hence the revenue, according to Baum.
Polivy’s upcoming data will arrive as Roche’s pharma business struggles with sales decline from its three cancer blockbusters—Rituxan, Herceptin and Avastin—as a result of U.S. biosimilar assault. In the first half of the year, biosimilars to the three drugs together bit CHF 2.85 billion off Roche’s topline.
As Anderson noted during the call, Roche has lost “significantly more than half” its sales from all three products in the U.S. The good thing about that? The decline from here on will be smaller, he said.
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COVID-19 drugs are among products that came to Roche’s help during these hard financial times. Roche’s sales share of Regeneron-partnered COVID-19 antibody therapy Ronapreve, a combination of casirivimab and imdevimab, reached CHF 429 million ($467 million) in the second quarter. That brings its total six-month haul in ex-U.S. markets that the Swiss pharma is responsible for to CHF 595 million ($648 million).
Japan on Tuesday became the first country to grant Ronapreve full approval to treat mild-to-moderate COVID-19. The drug is also under rolling review with the European Medicines Agency.
Thanks to its adoption in COVID-19, rheumatoid arthritis drug Actemra brought in CHF 863 million sales in the second quarter. It now ranks as Roche’s third best-selling drug by quarterly sales, behind multiple sclerosis antibody Ocrevus (CHF 1.21 billion) and HER2 cancer med Perjeta (CHF 980 million).
Overall, Roche’s pharma business returned to a 4% year-over-year sales growth at constant currencies, following a 9% decline in the first quarter. But as CEO Severin Schwan acknowledged during the call, the company has a very low base to compare to, given COVID-19 significantly slowed down pharmas’ performance a year ago.
Editor's Note: The story has been updated to change Bill Anderson's Polivy estimate to CHF 2 billion from the previous $2 billion.