GlaxoSmithKline plc GSK presented data from the phase I/II GARNET study on oncology candidate, dostarlimab at the 2019 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in Honolulu, Hawaii.
The study evaluated dostarlimab (formerly TSR-042), an investigational humanized anti-programmed death (PD)-1 monoclonal antibody, in women with recurrent or advanced endometrial cancer who progressed on or after a platinum-based regimen.
We note that endometrial cancer is the most common gynaecologic malignancy in the United States, with limited treatment options for women whose disease progresses on or after first-line therapy. Endometrial cancer can be classified as microsatellite stable (MSS/75%) or microsatellite instability-high (MSI-H/25%).
The study analysed 125 patients, including 41 MSI-H (33%), 79 MSS (63%) and 5 patients with an unknown MSI-status (4%). Dostarlimab was dosed at 500 mg once every 3 weeks for 4 doses, followed by 1000 mg once every 6 weeks until disease progression.
The results from the study showed clinically meaningful and durable response rates of dostarlimab in this patient population, regardless of microsatellite instability status. Moreover, the safety findings indicate that dostarlimab is well tolerated, with a safety profile consistent with that of an anti-PD therapy.
Glaxo plans to further analyse the data from the GARNET study, using the RECIST 1.1 criteria to support regulatory filing for the drug. The company expects to submit a Biologics License Application (BLA) for dostarlimab for the treatment of endometrial cancer at the end of 2019.
At the time of data cutoff, treatment was still ongoing in 84% of responders. Among these responders, 89% (33 of 37) have been on treatment for more than six months and 49% (18 of 37) for more than a year.
The GARNET study is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. The trial included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended phase II dose. Part 2B of the study includes four expansion cohorts — MSI-H endometrial cancer, MSI-H non-endometrial cancer, MSS endometrial cancer and non-small cell lung cancer (NSCLC).
In 2018, the FDA granted Breakthrough Therapy designation to Eisai’s orally available kinase inhibitor in combination with Merck's MRK anti-PD-1 therapy, Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or MSI-H/proficient mismatch repair (pMMR) endometrial carcinoma who have progressed following at least one prior systemic therapy.
Meanwhile, dostarlimab was added to GlaxoSmithKline’s pipeline, following the Tesaro acquisition in January 2019. The acquisition of Tesaro added ovarian cancer drug, Zejula to Glaxo’s portfolio, which will strengthen the latter’s position in the oncology market.
We note that stiff competition, genericization and pricing pressure on key drugs are hurting Glaxo’s top line. The FDA recently approved Mylan’s MYL generic version of Glaxo’s top-selling drug, Advair, which will adversely affect the drug’s sales. The company has undertaken restructuring initiatives to strengthen its business. It has also formed a joint venture with Pfizer PFE to create a premier global consumer healthcare company.
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