Mumbai: GSK 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 longterm 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, respectively10. 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.
About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1) – blocking antibody, is the backbone of GSK’s
ongoing immuno-oncology-based research and development programme. A robust clinical trial
programme includes studies of Jemperli alone and in combination with other therapies in
gynaecologic, colorectal and lung cancers, as well as where there are opportunities for
transformational outcomes.
In India, Jemperli is approved as monotherapy for the treatment of patients with mismatch repairdeficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial
cancer, whose disease has progressed on or after prior platinum-containing chemotherapy. This
approval provides a much-needed immunotherapy option in the second-line setting, where
existing treatments have historically been limited in both durability and clinical outcomes and exclusive license agreement signed in March 2014.
About Zejula (niraparib)
In India, Zejula is approved as once-daily oral PARP inhibitor approved as monotherapy for first
line maintenance treatment for patients with advanced or relapsed epithelial ovarian who are in
complete or partial response to platinum-based chemotherapy, regardless of biomarker status.
Zejula offers a convenient and effective maintenance option to help delay disease progression.
About GSK India
GlaxoSmithKline Pharmaceuticals Limited is a subsidiary of GlaxoSmithKline plc, a science-led
global healthcare company with a purpose to unite science, technology and talent to get ahead
of disease together.
