On March 5, 2021 Bristol Myers Squibb reported FDA’s recent approval for Breyanzi, a new pharma giant is entering the CAR-T lymphoma fray (Press release, FiercePharma, MAR 5, 2021, https://www.fiercepharma.com/pharma/ready-to-square-off-bms-breyanzi-novartis-exec-says-he-s-welcoming-car-t-competition [SID1234576175]). But with new, impressive real-world data and a global manufacturing expansion under its belt, rival Novartis says it’s ready to rumble.
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Novartis last year opened CAR-T production sites in Switzerland and France, while a partner opened a facility in Japan. Another partner, Cell Therapies, has since opened the first CAR-T manufacturing site in Australia. Now, the Swiss drugmaker can call on seven CAR-T manufacturing sites on four continents.
That’s a major advance, particularly after Novartis struggled with Kymriah supplies early on—and given the notorious difficulties that come with producing CAR-T treatments. With the new production sites, the company is "able to meet global demands." said Stefan Hendriks, Novartis’ global head of cell and gene therapies.
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Now, Bristol’s Breyanzi is entering the fray. The medicine won an FDA approval early last month, and a BMS exec contends the drug carries a "differentiated" profile featuring "rapidly occurring responses" and "durable responses."
But Novartis has 5-year data to spotlight—the longest follow-up data for an FDA-approved personalized lymphoma cell therapy, the researchers said. And the data show Kymriah delivers durable responses as well.
Among 24 Kymriah patients with diffuse large B-cell lymphoma, 46% were in complete remission and 31% achieved progression-free survival at five years, researchers with Penn’s Abramson Cancer Center reported last month. And among 14 patients with relapsed or refractory follicular lymphoma, 71% were in complete remission at five years. Forty-three percent of the relapsed/refractory follicular lymphoma patients achieved progression-free survival at five years.
The data show Kymriah is becoming "more and more proven in the real world," Hendriks said in an interview this week.
Novartis won the industry’s first FDA approval for a CAR-T therapy back in August 2017, when the agency endorsed Kymriah to treat a rare form of acute lymphoblastic leukemia. Gilead’s Yescarta scored an approval in relapsed or refractory large B-cell lymphoma a couple of months later, giving the Gilead drug a first-to-market advantage in the larger patient group. The following May, Novartis’ drug scored an FDA approval to match its rival in relapsed or refractory large B-Cell lymphoma.
CAR-T drugs are created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill cancer cells. Because of the complex nature of the process, manufacturing and logistics are key considerations for companies working to supply those treatments.
Novartis had some Kymirah supply problems early on. In late 2018, the company acknowledged some doses were not meeting quality specifications, and that it was giving them away to patients and doctors who asked. At the time, a spokeswoman said the company was "making improvements to our manufacturing process to increase efficiency and reduce variability."
RELATED: Novartis fills manufacturing gap for CAR-T therapy Kymriah with first Asian production facility
Now, with the supply wrinkles shaken out, around 290 sites worldwide are administering the drug, Hendriks said, and the drug is reimbursed in 27 countries.
Aside from that real-world data, other evidence has shown that a significant number of Kymriah patients can be treated in the outpatient setting, meaning they don’t have to stay in the hospital for long periods of time, Hendriks said. That’s "very beneficial" during the pandemic and has been "recognized" by doctors, he added. As a result, the company’s "market share has nicely grown" during the pandemic, Hendriks said.
Still, on the sales front, the company has some catching up to do against Gilead’s Yescarta. Gilead’s drug pulled in $563 million worldwide last year, while Novartis’ Kymriah generated $474 million. Moving forward, the third entrant from Bristol Myers Squibb will be wrestling for share.
Even though Novartis has been in cell therapy for years, Hendriks says it’s still early days for the field. The CAR-T class is still only reaching 20% of eligible patients, he said, and as more drugs launch, awareness among doctors and patients will grow. The Novartis exec said he’s "welcoming competition" as Novartis and others work to expand the reach for their medicines.
RELATED: Bristol Myers’ Breyanzi tunes its pitch for fight against entrenched CAR-T players Novartis and Gilead
Down the road, he sees the current generation of CAR-T therapies moving into earlier lines of treatment and fighting more cancers, including multiple myeloma. The Novartis exec also sees next-gen manufacturing platforms producing the drugs faster and more efficiently.