• The conversion of this indication from Notice of Compliance (NOC/c) to full approval (NOC) is based on long term outcomes from the GARNET phase I trial, which demonstrated an objective response rate of 45.5% in patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen
• This approval supports GSK's continued commitment to addressing the unmet needs of patients with gynaecological cancer

MISSISSAUGA, ON, July 24, 2024 /CNW/ - GSK today announced that Health Canada granted full approval for Jemperli (dostarlimab for injection) as a monotherapy for the treatment of adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen.

"We remain committed to exploring the full potential of Jemperli as the foundation of our immuno-oncology portfolio, aiming to meet the needs of patients in various stages of endometrial cancer and other types of solid tumours," said Marni Freeman, Country Medical Director at GSK Canada. "This approval in Canada reaffirms our belief in the value of Jemperli as a treatment choice for patients who are living with dMMR/MSI-H recurrent or advanced endometrial cancer."

This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial, a phase I, multicentre, open-label, single-arm study of Jemperli monotherapy in patients with advanced or recurrent solid tumours. Confirmed objective response rate (ORR) was 45.5% (95% CI: 37.1, 54.0), and the median duration of response (DOR) was not reached (range: (1.18+, 47.21+months), with a median follow-up for duration of response of 27.6 months.

In December 2021, Jemperli was granted NOC/c by Health Canada as a monotherapy for this indication in adult patients with dMMR or MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. Additionally, in November 2023, Jemperli in combination with carboplatin and paclitaxel was approved in Canada as a treatment option in combination with carboplatin and paclitaxel for adult patients with primary advanced or recurrent dMMR/MSI-H endometrial cancer in patients who are candidates for systemic therapy. Jemperli in combination with carboplatin and paclitaxel recently received positive funding recommendations from Canada's health technology assessment bodies and the file is now under active negotiation with the pan-Canadian Pharmaceutical Alliance (pCPA). GSK is committed to working with the pCPA and the drug programs to support widespread and timely access for primary advanced and recurrent endometrial cancer patients.

About endometrial cancer

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is one of the most common gynaecologic cancers in developed countriesⁱ with about 8,100 new cases of endometrial cancer diagnosed every year in Canada.ⁱⁱ Incidence rates are expected to rise by almost 40% by 2040.^{iii iv}  

Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. ^{v vi} An estimated 20-29% of all endometrial cancers are dMMR/MSI-H.^vii Chemotherapy has been the current standard of care for the majority of patients with primary advanced or recurrent endometrial cancer, and many patients eventually experience disease progression. ^viii

About GARNET

The ongoing GARNET phase I trial is evaluating Jemperli as monotherapy in patients with advanced solid tumours. Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut solid tumour basket cohort (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G).

About Jemperli (dostarlimab for injection)

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. ^ix

In Canada, Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy, and as monotherapy for the treatment of adult patients with dMMR or MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum containing regimen. Jemperli has also been accepted for review by Health Canada for an expanded indication in primary advanced endometrial cancer.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

GSK in gynaecologic oncology

GSK is committed to maximizing patient survival through transformational medicines with a current effort on breakthroughs in oncology, including gynaecologic cancers, some of the most common cancers affecting women. We are focused on developing new medicines across a range of different modalities both as monotherapy and in combination for a variety of cancers, including ovarian and endometrial. We have a unique research and development approach, utilizing synthetic lethality and immuno-oncology to target specific proteins and biomarkers in ovarian cancer and endometrial cancer, enabling us to develop targeted treatments.

About GSK

We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at gsk.ca.

References

SOURCE GlaxoSmithKline Inc.