Biotech
Indigenous CAR-T Cell Therapy Achieves Milestone in India – A Leap Forward for Cancer Treatment?
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There is a reason why cancer is called the emperor of all maladies. According to data presented by the Pan American Health Organization and World Health Organization in 2023, there were an estimated 20 million new cases of cancer and 10 million deaths from cancer.
The report anticipated the global cancer burden to increase by nearly 60% over the next two decades, creating a heavy load on healthcare, people, and communities. More specifically, the report projected the number of new cancer cases to become 30 million by 2040, with the steepest increase coming from low- and middle-income countries.
As a developing nation, India has taken the challenge head-on. According to publicly available reports, India's first patient to have used the indigenous CAR-T cell therapy has been declared cancer-free. The news has created much hope among cancer patients, medical professionals associated with cancer therapies, caregivers, and communities in general.
But why is this instance received with such zest? To comprehend, we would have to delve deeper.
India's Cancer Menace
Relief becomes equivalent to winning a war when the crisis is significant. According to reports published during mid-2023, the country is seeing a notable increase in detected cancer cases.
In 2022 alone, India had seen more than 1.46 million cases of cancer, with a death toll recorded at 808,000, a notable increase from 789,000 in 2021. Highlighting the gravity of the situation, the Indian Council of Medical Research (ICMR) reports that one in nine Indians will develop cancer during their lifetime. The country's government, too, has shared a projection, which estimates that the number of cancer cases detected will increase at an annual rate of 12.8%, resulting in close to 1.6 million cases by 2025.
Demographically, cancer poses more of a threat to Indian women than to Indian men. The ICMR study says that one in 68 men will develop lung cancer, and one in 29 women will develop breast cancer. What is even more worrying is the significant possibility of underreporting of cases. An Indian Chamber of Commerce study says that the actual incidence of the disease in India could be two to three times higher than the official figures.
Childhood cancers are also on the rise in India. A 2022 study carried out by BMC Public Health showed that childhood cancer was among the fifth leading cause of death in the age group of 5-14 years. While 50,000 new childhood cancer cases are reported every year, the number is expected to increase in the future.
According to Swagata Yadavar, an independent health journalist who covered the 2023 World Oncology Forum in Ascona, Switzerland:
“Cancer is the third-largest cause of death in our country after cardiovascular disease and chronic respiratory diseases. It is diagnosed very late in India, which is why only 30 percent of cancer patients survive five years after diagnosis.”
Medical professionals agree with Swagata Yadavar's assessment, as leading oncologists in India have recognized the delay in treatment as a barrier to eradicating cancer in the country.
Dr. Viswanathan Shanta, perhaps the most well-known Oncologist in India, once said:
“Fear not cancer diagnosis, but its delay.”
But much of this delay stems from Cancer patients fearing the humongous sum involved in cancer treatment. And that is where the indigenous CAR-T cell therapy has made a crucial intervention.
Click here to learn how precision therapies help treat the untreatable.
What is India's Indigenous CAR-T Cell Therapy?
In its original form, CAR-T cell therapies are a type of immunotherapy. The purpose of the intervention in this line of treatment is to modify the T cells in a laboratory to selectively kill cancer cells.
In October 2023, after much R&D, India's first indigenous CAR-T cell therapy got approval from the Central Drugs Standard Control Organization, India's counterpart to the United States Food and Drug Administration. ImmunoACT, a spin-off company from India's leading technology institute, IIT Bombay, funded the trial that led to the approval.
Summarily, there were two small clinical trials conducted among 64 people with advanced lymphoma or leukemia. The trial results were presented in December 2023 at the American Society of Haematology. The results reported a notable decrease in the extent of their cancer among 36 out of 53 patients, constituting 67% of the total patients surveyed. Out of this 67%, cancer disappeared altogether among 50% of the respondents.
After the trial results came out to be satisfactory and promising, NexCAR19 became available for commercial use. In India, the therapy is available in more than 30 hospitals in more than ten cities.
The Advantages of India's CAR-T Cell Therapy
On February 7th, 2024, India's first commercial patient to have accessed this therapy came out cancer-free. A gastroenterologist with nearly three decades of professional experience, Dr V K Gupta, accessed this therapy for US$50,000, while a similar therapy could cost up to US$480,000 overseas. The doctor who performed this therapy said:
“While it's premature to claim a lifelong cure, the patient is currently free of cancer cells.”
While pointing out its benefits, the doctors also said that the initial findings suggested “better survival chances and lower remission rates” for patients in the early stages of cancer.
The therapy is also highly inclusive as it can be applied to any patient aged above 15 suffering from B-cell cancers.
Click here to learn how CRISPR can help treat cancer.
The Cost-Effectiveness of India's CAR-T Cell Therapy
United States
In March 2021, the United States Food and Drug Administration approved the use of CAR-T cell therapy, also known as Chimeric Antigen Receptor (CAR) T-cell therapy. The treatment was priced at US$373,000 in the U.S.
Europe
Between 2018 and 2021, two CAR-T cell therapies received approval from the European Medicine Agency. In France, the therapy is available at a cost between 320,000 Euros and 350,000 Euros, whereas, in Germany, Netherlands, and Spain, the range is 320,000-327,000 Euros. In Italy, the listed price of the therapy falls within the range of 300,000-327,000, and in the United Kingdom, the therapy can be availed at a cost that hovers between 282,000 GBP and 300,000 GBP.
The indigenous CAR-T cell therapy, which, as noted earlier, is available at US$50,000 in India, is 6-7 times more cost-effective than the solutions available in the developed countries of Europe and the United States of America.
According to Nirali Shah, M.D., the NCI scientist instrumental in providing training to her Indian counterparts:
“The fact that they have been able to keep the costs low and come up with a [treatment] that is relatively well tolerated—which is important for the patient population they're going to be treating in India—means that they're going to [improve] the lives of so many people.”
However, not only scientists and oncology researchers but also multiple companies are active in the field whose aim is to introduce novel treatment methods to treat cancer. In the following segments, we will look into some such companies.
Companies Working on Novel Treatment Methods to Treat Cancer
#1. Serum Institute
In January 2023, the CEO of Serum Institute of India, Adar Poonawalla, announced the launch of the first indigenous vaccine for the prevention of Cervical Cancer. As reported during the launch, nearly 80,000 cervical cancer cases are reported in India every year. The daily death rate from cervical cancer in India is anywhere between 95 and 100. India also accounts for the majority of deaths from cervical cancer in the world.
According to Dr. NK Arora, the Chairman of the Covid working group, National Technical Advisory Group on Immunization:
“There are two or three companies that are in the process (of manufacturing the vaccine in India), but the Serum Institute of India has already got the regulators' clearance, and the vaccine should be available for our patients by April or May 2023.”
The indigenous vaccine was expected to be available at one-tenth of the average global cost.
Serum Institute of India Cervical Vaccine Cervavac is indicated in girls and women aged between 9 and 26 for protection from cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) of types 16 and 18. The vaccine is indicated in boys and men of the same age group for anal cancer caused by HPV types 16 and 18.
Serum Institute of India is presently the world's largest vaccine manufacturer by number of doses produced and sold globally, which is more than 1.5 billion doses.
According to a CRISIL credit rating document published on March 3rd, 2023, Serum Institute of India Private Limited has a diverse revenue profile driven by a wide portfolio of vaccines and a presence in around 170 countries.
The company's standalone revenue more than tripled in fiscal 2022 to Rs 25,646 crore (from 7,201 crore in fiscal 2021) due to large-scale sales of the Covid-19 vaccine in India, but plunged to ~Rs 5,500 crore in the first half of fiscal 2023 with a decline in the demand for the Covid-19 vaccine in the domestic market.
#2. Novartis
Another well-known business that has been doing great in oncology innovation is Novartis. In fact, the Novartis Oncology team has developed a healthy treatment portfolio for cancer, which includes CAR-T cell therapies, Targeted Radiogland therapies, and novel small molecules.
When it comes to targeted radio-gland therapy, radioactive isotopes are attached to proteins that home in on cancer cell targets with high precision. The targeting is so precise that healthy tissues are spared. Novartis is also developing small molecules against targets that were previously considered undruggable.
In India, Novartis has had a significant presence since 1947, with its services focused on drug development, manufacturing, and commercial and social business services. The company operates through two legal wings in the country, namely Novartis Healthcare Private Limited (NHPL) and Novartis India Limited (NIL). Together, both of these entities employ close to 10,000 people in the country.
Novartis AG (NVS +0.16%)
For the financial year ending on December 31st, 2023, Novartis registered more than US$45 billion in net sales from continuing operations. The net income of the company was more than US$8.5 billion.
#3. Roche
Roche's focus on solving the oncology problem in India has been commendable as well. Its Blue Tree program has been specifically devised for India. The program aims to support cancer patients from diagnosis to completion of their treatment. It is open to everyone, irrespective of the patient's ability to pay.
Roche sees the act of treating cancer as a combination of diagnosis, affordability, and adherence. In the diagnosis segment, Roche helps patients and doctors make informed decisions on the best possible treatment of a range of cancers, including those affecting the breast, lung, ovary, and more.
The company offers free biomarker tests for patients who can not afford best-in-class testing facilities. The adherence segment facilities connect patients with Roche's medicine access initiative, making all of Roche's key oncology products available.
By the end of 2020, more than 7,000 patients availed of the Blue Tree program benefits. The services were made available in over 500 hospitals and treatment centers. The patients who accessed the program exhibited a 40% increase in therapy adherence rates. Meanwhile, Roche has also been working on increasing access to its oncology products in other lower-middle-income countries like India.
Rogers Corporation (ROG -0.63%)
In 2023, Roche reported annual sales of CHF 58.7 billion – an increase of 1% at constant exchange rates.
Treating Cancer is About the Right Care at the Right Time
The menace of cancer is a long-recognized one, with oncology researchers worldwide devising newer solutions to combat it. Alongside, global efforts are underway to make these cures and solutions available at affordable rates, aiming to bridge the gap in healthcare accessibility. These consolidated efforts are directed at making early detection an efficient and effective reality, underscoring the importance of timely intervention.
Curing cancer revolves around making the best care affordable at the right time, ensuring treatments are inclusive. This approach is particularly crucial for the underprivileged population, especially in countries like India, where access to healthcare without life-shattering expenses is vital. Through novel techniques and their indigenous adaptations, improving the scenario for those affected by cancer is certainly within reach.
