Preventive Healthcare
Qartemi: India’s Revolutionary CAR T Therapy for Blood Cancer
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In a significant breakthrough for blood cancer treatment in India, Immuneel Therapeutics has launched Qartemi, a revolutionary CAR T-cell therapy specifically designed for adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This innovative blood cancer therapy harnesses the power of the patient's own immune system to fight cancer, offering new hope to those who have exhausted conventional treatment options.
With approximately 120,000 new cases and over 70,000 deaths annually from leukemia, lymphoma, and multiple myeloma in India, the burden of blood cancers is substantial. The Qartemi drug marks a crucial step towards making advanced, life-saving treatments more accessible to Indian patients, shifting the paradigm towards a cure for blood cancer.
What is Qartemi, and how does it utilise CAR-T therapy?
Qartemi is India's first globally benchmarked CAR T-cell treatment specifically designed for adult B-cell non-Hodgkin lymphoma. This innovative therapy, seen as a significant step towards a cure for blood cancer, involves genetically modifying the patient's own T cells to recognise and attack cancer cells.
Here's a step-by-step overview of how the Qartemi drug works:
- T Cell Extraction: The patient's T cells, a type of white blood cell crucial for immune response, are collected from their blood.
- Genetic Modification: These T cells are then genetically engineered in a laboratory to express a chimeric antigen receptor (CAR) on their surface. This CAR is specifically designed to target a protein called CD19, which is found on the surface of B-cell lymphoma cells.
- CAR T-Cell Expansion: The genetically modified CAR T cells are multiplied in the lab to create millions of cancer-fighting cells.
- Reinfusion: The expanded CAR T cells are then infused back into the patient's bloodstream, where they seek out and destroy the cancer cells expressing the CD19 antigen.
Significance of Qartemi in India
The launch of the Qartemi drug holds immense significance for India, given the country's growing burden of blood cancers. Consider these alarming statistics:
- India witnesses approximately 120,000 new cases and over 70,000 deaths annually due to blood cancers such as leukemia, lymphoma, and multiple myeloma.
- Approximately 40,000 new cases of non-Hodgkin Lymphoma (NHL) are diagnosed in India each year.
- Access to advanced cancer treatments remains a significant challenge for many Indian patients due to financial constraints and limited availability.
The Qartemi drug addresses these challenges by providing a globally benchmarked CAR T cancer treatment at a significantly more accessible price compared to international alternatives. Developed and manufactured indigenously by Immuneel Therapeutics, Qartemi ensures that Indian patients have access to cutting-edge, life-saving therapies right here at home.
Qartemi Approval by CDSCO
Qartemi has been rigorously evaluated and approved by the Central Drugs Standard Control Organisation (CDSCO), India's apex regulatory body for pharmaceuticals and medical devices. This approval follows the successful completion of the IMAGINE trial, which demonstrated the safety and efficacy of Qartemi in treating adult patients with B-NHL.
The IMAGINE trial, conducted across multiple hospitals in India, including Narayana Hospital, Apollo Cancer Hospital, and PGIMER, showed impressive results:
- An overall response rate (ORR) of 83.3% at Day+90, setting a new benchmark for CAR T-cell therapy in India.
- No patients required ICU admissions or developed neurotoxicity, indicating a favorable safety profile similar to other approved CAR T-cell therapies.
The CDSCO's approval of Qartemi based on these positive clinical trial outcomes marks a significant step forward in bringing this revolutionary treatment to patients in need.
How Qartemi Works
To understand how Qartemi works, let's take a closer look at the science behind CAR T-cell immunotherapy:
- T Cell Extraction: The process begins by collecting T cells, a type of white blood cell essential for immune response, from the patient's blood through a procedure called leukapheresis.
- Genetic Modification: The extracted T cells are sent to a specialised laboratory, where they undergo genetic engineering. Using a harmless virus as a vehicle, the T cells are modified to express a chimeric antigen receptor (CAR) on their surface. This CAR is specifically designed to recognise and bind to the CD19 antigen found on B-cell lymphoma cells.
- CAR T-Cell Expansion: The genetically modified CAR T cells are then multiplied in the laboratory to create millions of cancer-fighting cells. This expansion process ensures that there are enough CAR T cells to mount a strong immune response against the cancer.
- Reinfusion: Once the CAR T cells have been expanded, they are infused back into the patient's bloodstream. The infusion process is similar to a standard blood transfusion and typically takes less than an hour.
- Cancer Cell Destruction: After reinfusion, the CAR T cells circulate throughout the patient's body, seeking out and binding to the CD19 antigen on the surface of B-cell lymphoma cells. Upon binding, the CAR T cells become activated and release cytotoxic molecules that destroy the cancer cells.
- Ongoing Surveillance: One of the remarkable features of CAR T-cell therapy is that the modified T-cells can persist in the patient's body for months or even years after the initial treatment. These long-lasting CAR T cells continue to monitor for any remaining or recurring cancer cells, providing ongoing protection against relapse.
Benefits of Qartemi
Qartemi offers several significant benefits for patients battling B-cell non-Hodgkin lymphoma:
- High Efficacy: The IMAGINE trial demonstrated an impressive overall response rate of 83.3% at Day+90, indicating that Qartemi is highly effective in treating adult B-NHL patients who have exhausted other treatment options.
- Favorable Safety Profile: Unlike some other cancer treatments, Qartemi has shown a favorable safety profile, with no patients in the IMAGINE trial requiring ICU admissions or developing neurotoxicity.
- Personalised Treatment: Qartemi is a personalised therapy that uses the patient's own immune cells to fight cancer. This tailored approach ensures that the treatment is specific to each individual patient, potentially reducing the risk of side effects and improving outcomes.
- Accessibility: Developed and manufactured in India, Qartemi is priced significantly lower than global CAR-T cell treatment alternatives. This affordability makes the treatment more accessible to Indian patients who may otherwise struggle to afford such advanced therapies.
Eligibility for Qartemi Treatment
To be eligible for Qartemi treatment, patients must meet certain criteria:
- Diagnosis of relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) after exhausting other treatment options.
- Adequate organ function and overall health status to tolerate the treatment process.
- No active infections or severe comorbidities that could compromise the immune system.
- Willingness and ability to comply with the treatment protocol and follow-up requirements.
Patients interested in exploring Qartemi as a treatment option should consult with their oncologist or haematologist to determine their eligibility and discuss the potential risks and benefits of the therapy.
Cost and Accessibility
One of the most remarkable aspects of Qartemi is its affordability. While similar blood cancer therapy abroad cost between $600,000 and $700,000, Qartemi is priced significantly lower, ranging from Rs 35 lakh to Rs 50 lakh. By combining world-class CAR-T therapy with indigenous manufacturing, Immuneel Therapeutics has taken a significant step toward making this advanced treatment more accessible to Indian patients.
However, challenges persist. CAR T cancer treatment is not yet covered by insurance in India, making it financially burdensome for many patients. Additionally, the treatment requires hospitalisation, adding to the overall cost and complexity.
Despite these hurdles, Qartemi marks an important advancement in the quest for a widely accessible cure for blood cancer, offering hope to thousands of patients across the country.
Side Effects and Risks
As with any advanced medical treatment, Qartemi comes with potential side effects and risks. Some of the most common ones include:
- Cytokine Release Syndrome (CRS): Patients may experience high fever, chills, trouble breathing, severe nausea, vomiting, diarrhoea, dizziness, headaches, fast heartbeat, and muscle or joint pain.
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Symptoms can include headaches, changes in consciousness, confusion, agitation, seizures, tremors, trouble speaking and understanding, and loss of balance.
- Other serious side effects: These may include allergic reactions, abnormal mineral levels in the blood, weakened immune system, low blood cell counts, and an increased risk of developing another type of blood cancer.
What Role Will Qartemi Play in Shaping the Future of CAR-T Therapy in India?
Qartemi is set to revolutionise cancer treatment in India by offering a highly effective yet affordable CAR T cancer treatment option. Its approval and availability mark a significant milestone in making advanced cancer therapies accessible to a broader population.
By partnering with leading hospitals across the country, Immuneel Therapeutics aims to expand access to this life-saving treatment. This collaboration will help build the necessary expertise and facilities to administer CAR-T therapy safely and effectively.
As more patients benefit from Qartemi and similar treatments, it will likely spur further research and development in the field of T-cell immunotherapy in India. This could lead to the development of CAR T cells targeting other types of cancers, potentially offering hope to even more patients.
Conclusion
While it's not a magic cure for blood cancer, Qartemi is a powerful tool in the hands of skilled oncologists. As with any medical treatment, it's essential to consult with a trusted healthcare provider to determine if Qartemi is the right choice for you or your loved one.
If you're considering Qartemi or need to monitor your health during treatment, Metropolis Healthcare can be your trusted partner. With a wide network of diagnostic labs across India, Metropolis offers accurate pathology testing and health check-up services. Their team of qualified technicians can collect blood samples from the comfort of your home, with reports conveniently shared online. By delivering reliable results and personalised care, Metropolis empowers you to prioritise your health throughout your cancer journey.
FAQs
What is Qartemi?
Qartemi is India's first affordable CAR T cell treatment for adult B-cell Non-Hodgkin Lymphoma (B-NHL). It is a personalised T-cell immunotherapy that involves extracting a patient's T-cells, genetically modifying them to target cancer cells, and reinfusing these modified cells into the patient.
Which types of cancer can Qartemi treat?
Qartemi is specifically designed to treat adult B-cell Non-Hodgkin Lymphoma (B-NHL), particularly in cases where the disease has relapsed or is at an advanced stage.
Who is eligible for Qartemi therapy?
Qartemi's blood cancer therapy is eligible for adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. Eligibility involves a comprehensive medical evaluation to ensure the patient can tolerate the treatment and has no contraindications.
What is the cost of Qartemi therapy in India?
Qartemi's blood cancer therapy in India is priced significantly lower than similar CAR T cancer treatments abroad, which typically cost between ₹5 crore and ₹6 crore. In comparison, Qartemi is available for ₹35 lakh to ₹50 lakh, making it approximately one-tenth the cost. This affordability reflects Immuneel Therapeutics' commitment to making advanced cancer therapies more accessible to patients in India.
Are there any risks or side effects of Qartemi therapy?
Yes, Qartemi therapy can have several side effects and risks, similar to other CAR-T therapies. These include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), allergic reactions, abnormal mineral levels, weakened immune system, low blood cell counts, and an increased risk of developing another blood cancer.
How long does Qartemi therapy take?
The duration of Qartemi therapy can vary, but it generally involves several steps, including T cell collection, chimeric antigen receptor modification, and infusion. Patients typically need close monitoring for several weeks after the treatment due to the potential for serious side effects.
Is CAR-T therapy available in all hospitals in India?
No. Qartemi is currently offered by select leading hospitals in India that have the necessary expertise and facilities. These include Narayana Hospital, Apollo Cancer Hospital, PGIMER, Manipal Hospitals, Apollo Hospitals, CMC Vellore, RGCIRC Delhi, and SGPGI Lucknow, among others.