Immuneel Therapeutics, a cell and gene therapy start-up based in Bengaluru, has launched Qartemi, a CAR T-cell therapy for treating adult B-cell Non-Hodgkin Lymphoma (B-NHL). This marks a significant advancement in India's cancer immunotherapy landscape, offering a personalized treatment option for patients with relapsed or refractory B-NHL.
Qartemi, also known as varnimcabtagene autoleucel (IMN-003A), has been approved by the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO), and is licensed from Hospital Clinic de Barcelona (HCB) in Spain. The therapy involves modifying a patient’s T-cells to specifically target and destroy cancer cells, offering a potential for lasting remission even when conventional therapies like chemotherapy prove ineffective.
Clinical Efficacy and Safety
Clinical trials for Qartemi, conducted in India and Spain, have demonstrated safety and efficacy comparable to CAR T-cell therapies approved by the US Food and Drug Administration (FDA). In a Phase 2 trial, Qartemi achieved an overall response rate (ORR) of 83.3%, setting a new benchmark for CAR-T therapy in India, according to Immuneel. The therapy has been tested in blood cancer patients across Narayana Hospital in Bengaluru, Apollo Cancer Hospital in Chennai, and Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh.
Addressing a Critical Need
India faces a rising burden of blood cancers, with approximately 120,000 new cases and over 70,000 deaths annually from leukemia, lymphoma, and multiple myeloma. Qartemi addresses a critical gap in treatment options for patients with relapsed or refractory B-NHL, for whom conventional therapies have failed.
Cost and Accessibility
Qartemi is priced between ₹35 lakh and ₹50 lakh, significantly lower than the cost of similar CAR T-cell therapies in the United States, which can range from $350,000 to $700,000. According to Kiran Mazumdar-Shaw, Board Director & Co-Founder of Immuneel Therapeutics, this pricing strategy aims to make the therapy accessible to Indian patients without compromising on quality. Immuneel has partnered with over 25 hospitals across India to provide access to Qartemi, including Narayana Health, Apollo Hospitals, Christian Medical College in Vellore & Ludhiana, and Manipal Hospitals.
How Qartemi Works
CAR T-cell therapy involves extracting a patient's T-cells, a type of white blood cell, and genetically engineering them to recognize and attack cancer cells more effectively. This is achieved by adding a manufactured CAR (chimeric antigen receptor) to the T-cells. These modified T-cells, now called CAR-T cells, are then infused back into the patient's bloodstream, where they target and destroy cancer cells expressing the CD19 protein. Both Qartemi and NexCAR19, another CAR-T cell therapy approved in India, target CD19.
Expert Perspectives
Dr. Siddhartha Mukherjee, Board Director & Co-Founder of Immuneel Therapeutics, emphasized the importance of combining world-class research with indigenous manufacturing to offer new hope to patients facing aggressive blood cancers. He stated that this approach not only provides a breakthrough treatment but also redefines what is possible in precision medicine.
Future Directions
While CAR T-cell therapy is currently approved for blood cancers, research is underway to assess its potential in treating solid tumors. Additionally, efforts are ongoing to develop more affordable CAR T-cell products for patients in developing countries like India. Clinician-researchers at AIIMS are developing a CAR-T product targeting B Cell Maturation Antigen (BCMA) protein to treat multiple myeloma, with clinical trials expected to begin soon.
