Novartis is hoping a third indication will help position Kymriah better against Gilead Sciences’ rival Yescarta in the CAR-T race—and it has positive early clinical results to back its case.
Kymriah has hit its goal of eradicating signs of cancer in patients with relapsed or refractory follicular lymphoma (r/r FL) at an interim analysis of the phase 2 Elara trial, Novartis said Tuesday. But the news comes on the heels of Gilead touting a similar win in indolent non-Hodgkin lymphoma, which encompasses FL.
While details on Kymriah’s complete response rate remain under wraps, the Swiss pharma said it plans to use the data in regulatory filings in the U.S., expected in 2021, and the EU after that. The drug bears an FDA “regenerative medicine advanced therapy” designation, which could expedite its review process.
However, Yescarta may be one step ahead of Kymriah in FL. At this year's American Society of Clinical Oncology virtual event, Gilead unveiled data showing Yescarta cleared cancer completely in 80% of indolent NHL patients in a phase 2 trial. Based on that showing, Gilead's planning an FDA filing this year.
FL is the second most common form of non-Hodgkin lymphoma, representing about 22% of all cases. Kymriah, after its initial FDA nod in acute lymphoblastic leukemia in 2017, has been allowed since May 2018 as a third-line treatment for relapsed or refractory large B-cell lymphoma, which is the most prevalent NHL subtype.
However, despite having two indications in bag, Kymriah sales still have been lagging behind those of Yescarta, which went after large B-cell lymphoma for its first—and so far its only—indication. In the first half of 2020, Kymriah sales totaled $211 million, while Yescarta brought in $296 million.
Kymriah’s slower uptake was partly the result of an initial manufacturing hiccup as it struggled to meet commercial specifications as required by the FDA. That issue has been resolved now.
Novartis expanded its global manufacturing capacity by 75% in the first half of 2020 compared with the previous year, with recent approvals from the European Medicines Agency for manufacturing at its own facilities in Stein, Switzerland, and in Les Ulis, France, Novartis Oncology president Susanne Schaffert told investors during a conference call in July.
Gilead is ramping up its own manufacturing as well. The company’s 117,000-square-foot CAR-T facility at SEGRO Park Amsterdam Airport recently became fully operational after EMA approval.
The U.S. Big Biotech also last month bagged an FDA go-ahead for its second CAR-T drug, Tecartus, for previously treated mantle cell lymphoma.