Two old drugs just learned new tricks.
Celgene’s blood cancer stalwart Revlimid and Roche’s megablockbuster Rituxan won FDA approval as a chemo-free combination therapy for previously treated follicular or marginal zone lymphomas. The regimen has a stylish code name—R2—and promises a hefty sales boost for Celgene.
“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” Celgene’s chief medical officer Jay Backstrom said in a Wednesday statement. Given its role as the centerpiece of Bristol-Myers Squibb's $74 billion Celgene buyout, that's a good thing for both companies.
For patients, R2 is the first chemo-free regimen for these indolent forms of non-Hodgkin lymphoma (NHL), Celgene said. Follicular lymphoma and marginal zone lymphoma account for 22% and 7% of adult NHL cases, respectively. These indolent NHLs are marked by immune dysfunction, where lymphocytes either fail to detect or target cancer cells.
The approval was primarily based on results from the phase 3 Augment study. Treatment with R2 stalled tumor progression for a median of 39.4 months, versus 14.1 months with Rituxan and placebo. The combination didn’t show a statistically significant improvement at extending patients’ lives, though Celgene pointed out “a numeric trend.” The two-year survival rate was 93% for patients receiving R2, compared with 87% in the control arm.
SVB Leerink analyst Geoffrey Porges was impressed with the 39-month profession-free survival benefit when the data were unveiled last November. R2’s performance “appears to be superior” to what’s expected from immunotherapy-chemo combinations based on past results, he said in a note to clients at the time. He projected the drug could add an additional $600 million in yearly revenue from the indication.
Ritxuan, in tandem with chemo, is already used as an initial treatment for follicular lymphoma, and it’s used alone to prevent recurrence.
Celgene and Roche have been looking at new opportunities for these two older cancer therapies, despite their age. Celgene recently fended off a Dr. Reddy’s bid to invalidate three Revlimid patents at the U.S. Patent and Trademark Office, a key win for the megablockbuster. Revlimid pulled in $9.7 billion last year.
Rituxan isn’t so lucky. It has already gone off the patent cliff in the EU and could face biosimilar attack in the U.S. this year. The FDA has greenlighted Celltrion and Teva Pharmaceutical’s copycat version Truxima, which Roche expects to enter the market before year's end. In Europe, where knockoffs have already hit, Rituxan sales have been slashed in half.
To brace for the upcoming decline in the U.S., Roche is busy adding new indications. The FDA just recently granted priority review to a regimen that combines Rituxan with Roche’s first-in-class anti-CD79b antibody-drug conjugate polatuzumab vedotin in previously treated diffuse large B-cell lymphoma.