GSK Forays into Oncology in India with Jemperli and Zejula

KOCHI:

GSK today announced the availability of its much-awaited advanced therapies Jemperli (dostarlimab) and Zejula (niraparib) in India, marking its commitment to addressing the unmet need for specialised treatments in cancer care.

Gynaecological cancers are among the most common cancers in women in India and are on the rise . Endometrial and ovarian cancers are among the top three gynecological cancers in India. By 2045, the incidence of endometrial and ovarian cancer in India is projected to increase by 78% and 69% respectively.

Endometrial cancer is a malignancy arising out of the endometrium, the inner lining of the uterus. Nearly a fourth of endometrial cancer patients in India are at an advanced stage. At this stage, chemotherapy remains a standard treatment but it is often associated with toxicity and poor long-term outcomes.

Jemperli is the first and only approved PD-1 immunotherapy for the second-line treatment of mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) advanced or recurrent endometrial cancer, in India. Jemperli works by blocking the PD-1 pathway, a mechanism that cancer cells use to evade immune detection, thereby enabling immune cells to recognise and attack the tumour more effectively.

Jemperli’s efficacy is based on scientific evidence from the GARNET trial in patients with dMMR/MSI-H advanced or recurrent endometrial cancer . The study demonstrated that Jemperli achieved an objective response rate of 45.5%, with an estimated probability of maintained response of 93.3% and 83.7% at 12 and 24 months, respectively . Combined with an acceptable safety profile, these findings highlight the potential for durable clinical benefit in a population where standard chemotherapy has historically offered limited efficacy and poor long-term outcomes.

Ovarian cancer is a malignancy which begins in the ovaries which are located on each side of the uterus . Zejula is the only PARP inhibitor approved as first-line monotherapy maintenance for all biomarker types in advanced ovarian cancer, in India. It offers a once-daily oral dose, making it a simple and convenient option for patients. The updated ad-hoc analysis of the phase-3 PRIMA trial demonstrated that Zejula first-line maintenance monotherapy provided durable, long-term remission in women with newly diagnosed advanced ovarian cancer. These women were at high risk for disease progression or death across all biomarker subgroups.

To empower patients to access these innovative therapies, GSK is introducing ‘Phoenix’, a Patient Support Program.

Bhushan Akshikar, Managing Director, GSK India, said: “The launch of Jemperli and Zejula marks a pivotal moment for GSK in India, as we foray into oncology with a strong focus on innovation-led, high-impact therapies. These therapies address a critical unmet need in gynaecological cancers in India and represent meaningful progress in women’s cancer care. With this launch, we are strengthening our long-term commitment to build the specialty medicine portfolio in India.”

Dr. Shalini Menon, EVP – Medical Affairs, GSK India, said: “Gynaecological cancers represent a growing public health challenge in India, especially among women above the age of 50, and those with obesity and metabolic syndrome. Jemperli introduces immunotherapy into the treatment paradigm for advanced or recurrent endometrial cancer, offering a targeted option for patients with dMMR tumours. Zejula expands access to a convenient, first-line maintenance therapy in advanced ovarian cancer.”

The molecules launched are supported by robust global clinical evidence and approvals from across 40+ countries including the US, UK and EU. In India, GSK is participating in ongoing oncology clinical trials aimed to extend the indication of dostarlimab to other cancers including non-small cell lung, head and neck and colorectal.