Immunoadoptive Cell Therapy Private Limited (ImmunoACT)’s NexCAR19 (actalycabtagene autoleucel) chimeric antigen receptor T-cell (CAR-T) therapy was approved in October by the Central Drug Standards Control Organisation (CDSCO) of India for the treatment of relapsed or refractory (r/r) B-cell lymphomas and leukemia. With the approval, ImmunoACT is set to lead the journey of indigenous CAR-T cell therapy in the country, but the drug is expected to face market access challenges in India, says GlobalData, a leading data and analytics company.

The approval was based on the results of a multicenter Phase I/II pivotal trial conducted in India on 60 subjects with r/r B-cell lymphomas and leukemia. NexCAR19, used as second-line therapy, showed a 70% overall response rate and a significant delay in cancer progression, with manageable toxicity.

The current marketed CAR-T cell therapies approved for B-cell lymphomas are Kymriah by Novartis; Yescarta & Tecartus from Gilead; and Breyanzi by Bristol-Myers Squibb Co. However, none of the approved CAR-T therapies are available in India. The current treatment regime for B-cell lymphomas in India is largely dependent on the CD20 monoclonal antibody– rituximab in combination with other chemotherapeutic agents. NexCAR19 is the first CAR-T cell therapy approved in India.

Jithendra Kancharla, Pharma Analyst at GlobalData, comments: “The advent of indigenous CAR-T cell therapy is a significant milestone in India’s growing R&D prowess. As per ImmunoACT CEO, NexCAR19 will be available at a price of INR 30-40 lakh ($36,000- $48,000), which is 1/10^th of the cost of already approved therapies across the globe. This might increase medical tourism to India by providing access to exclusive therapy at a very low cost. However, it is still unaffordable for many in India.

“Along with the cost of the therapy, pre- and post-infusion maintenance add to the treatment expenses. CAR-T production and infusion require specialized facilities and skilled labor, often found only in major metropolitan cities. The possible side effects of CAR-T therapies require continuous patient monitoring for a certain period and very frequently lead to hospitalization. This demands patients’ relocation to access these critical therapies, posing a significant challenge in India.”

According to GlobalData’s Pharmaceutical Intelligence Center, the number of 10-year diagnosed prevalent cases of Diffuse Large B-cell lymphoma (DLBCL) in India is expected to increase at an annual growth rate (AGR) of 1.7% from 42,433 in 2023 to 44,940 in 2027. India has the second-highest AGR for DLBCL among the major markets, only next to the US.

NexCAR19 is currently under clinical investigation for other types of lymphomas and leukemia in several Phase II trials. Immuneel Therapeutics’ IMN-003A CAR-T is also in Phase II for B-cell lymphomas and leukemia. The successful completion of these trials would further cater to the critical need for effective cancer therapies in India.

Jithendra concludes: “India falls behind other major markets* where pharmaceutical companies, insurance companies, and federal agencies provide financial support for critical therapies. Since Immuneel Therapeutics’ CAR-T is currently in Phase II development, ImmunoACT may eventually need to compete with it. As such, developing an efficient pricing strategy is essential to foray into the Indian market. Companies should also focus on efficient patient support programs and establish sufficient infusion centers across India, ensuring the accessibility of indigenous therapies in the Indian healthcare landscape.”

*Major markets include Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, the UK, and the US.