CAR T-cell therapy is a significant advancement in cancer treatment, offering a new approach to tackling certain types of malignancies. This innovative method harnesses the body’s own immune system, specifically T-cells, to identify and attack cancer cells. Its emergence within the Indian medical landscape brings new possibilities for patients, reflecting a broader trend in personalized cancer immunotherapy.
What is CAR T-Cell Therapy
Chimeric Antigen Receptor (CAR) T-cell therapy is a specialized form of immunotherapy that modifies a patient’s own T-cells to enhance their ability to fight cancer. T-cells are extracted from the patient’s blood and genetically engineered in a laboratory. They are given a new structure on their surface called a Chimeric Antigen Receptor (CAR).
This CAR is designed to recognize and bind to specific proteins, known as antigens, found on cancer cells. This allows the modified T-cells to specifically identify and destroy malignant cells while minimizing harm to healthy tissues. Once infused back into the patient, these CAR T-cells can multiply and persist, acting as a “living drug” that continues to seek out and eliminate cancer.
CAR T-Cell Therapy’s Presence in India
India has made significant strides in making CAR T-cell therapy available. The Central Drugs Standard Control Organisation (CDSCO) approved the country’s first indigenous CAR T-cell therapy, NexCAR19 (actalycabtagene autoleucel), in October 2023. This offers a more affordable option for patients. NexCAR19 was developed through a collaborative effort between the Indian Institute of Technology (IIT) Bombay and Tata Memorial Hospital in Mumbai.
The therapy is currently approved for treating certain types of blood cancers, specifically relapsed or refractory B-cell lymphomas and leukemia. Clinical trials for NexCAR19 involved 64 patients with advanced lymphoma or leukemia, showing promising results with a 67% objective response rate and approximately half of the patients achieving complete remission. Researchers noted that NexCAR19 demonstrated a favorable safety profile with fewer severe side effects, including no reported neurologic complications and only 5% experiencing severe cytokine release syndrome, compared to some international therapies. ImmunoACT, an IIT Bombay spin-off company, is responsible for manufacturing and bringing NexCAR19 to market, with plans to expand manufacturing facilities across India.
The Patient Journey for Treatment in India
The patient journey for CAR T-cell therapy in India begins with an initial diagnosis of a specific blood cancer, such as acute lymphoblastic leukemia, diffuse large B-cell lymphoma, or multiple myeloma. This is followed by a referral to a specialized CAR T-cell therapy center. Eligibility criteria are stringent, usually involving patients who have exhausted other treatment options like chemotherapy or radiation, and are facing relapsed or refractory cases. Patients must also be in stable general health to withstand the intensive treatment regimen.
Once deemed eligible, the patient undergoes leukapheresis, a procedure where T-cells are separated from blood. These T-cells are then sent to a specialized laboratory for manufacturing and engineering. Here, they are genetically modified to express Chimeric Antigen Receptors (CARs) and expanded in number over several weeks.
Before infusion, patients typically receive a short course of chemotherapy, known as conditioning therapy, to prepare their body. The engineered CAR T-cells are then infused intravenously, usually taking about 30 minutes to an hour. Following infusion, patients are closely monitored for several weeks, often requiring a hospital stay of at least 8 days, and then needing to remain close to the treatment center for about four weeks to manage potential side effects such as cytokine release syndrome or neurotoxicity.
Cost Considerations for CAR T-Cell Therapy in India
The cost of CAR T-cell therapy in India presents a significant financial consideration. Indigenous therapies like NexCAR19 are substantially more affordable than international alternatives. While global CAR T-cell therapies can cost between $373,000 to $475,000, NexCAR19 is priced at approximately $30,000 to $50,000 (around INR 30-40 lakhs to 75 lakhs). This makes it one of the most cost-effective CAR T-cell therapies globally.
Components contributing to the overall cost include therapy development and manufacturing, specialized laboratory charges, hospitalization duration, and supportive medications. The personalized nature of the treatment also adds to expenses. To address these high costs, avenues for financial support are emerging. Government schemes and private insurance coverage are gradually expanding to include CAR T-cell therapy, though comprehensive coverage may still vary. Institutional patient assistance programs and charitable organizations can also provide support.
The Future of CAR T-Cell Therapy in India
The outlook for CAR T-cell therapy in India is marked by ongoing advancements aimed at expanding its reach and affordability. Research and development efforts continue, focusing on developing new CAR T-cell products and improving existing ones. This includes exploring therapies for a wider range of cancers beyond currently approved blood malignancies, potentially extending to solid tumors.
Efforts are also underway to make the therapy more accessible and affordable to a broader patient population. Local manufacturing initiatives, like those for NexCAR19, are scaling up to increase production capacity, with aims to treat around 1,200 patients annually. The regulatory landscape is evolving to streamline approval processes for cell and gene therapies, which will further facilitate their availability. Collaboration between academic institutions, industry, and government bodies is accelerating these developments, positioning India as a significant player in the global CAR T-cell therapy landscape.