JEMPERLI 500 mg (dostarlimab)

Key points

Unfavourable opinion for reimbursement in the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

Role in the care pathway?

The management of recurrent or advanced endometrial cancer is based on European (ESMO) and French guidelines.

Depending on the extent, location, histology and the patient’s general condition, surgery, radiotherapy, chemotherapy or endocrine therapy may be envisaged as treatment options.

In early stages of the disease (FIGO stages I and II), management is based on surgery and adapted depending on the severity of the disease and lymph node involvement, with:

• For low-risk cancers: surgery alone.
•  For intermediate-risk cancers: surgery combined with brachytherapy, radiotherapy.
• For high-risk cancers: surgery combined with brachytherapy, chemotherapy and external radiotherapy.

At the advanced stage of the disease (FIGO stage III), combination of platinum-based chemotherapy and radiotherapy is recommended.

At the metastatic stage of the disease (FIGO stage IV), the standard first-line treatment is carboplatin-based chemotherapy and paclitaxel every 21 days for 6 cycles. Dual cisplatin and doxorubicin chemotherapy or triple cisplatin, doxorubicin and paclitaxel chemotherapy are options, but present haematological toxicity.

There is limited data concerning the use of second-line chemotherapy in patients with recurrent endometrial cancer following the failure of platinum-based chemotherapy. Numerous therapeutic options are cited in the guidelines, without ranking by priority.

Role of JEMPERLI (dostarlimab) in the care pathway:

Considering:

• the very preliminary nature of the available efficacy data, based primarily on the results of a phase 1 non-comparative study (GARNET) not meeting the Committee’s minimum requirements to provide formal evidence of the clinical benefit of JEMPERLI (dostarlimab),
• the absence of robust comparative data enabling assessment of the contribution of JEMPERLI (dostarlimab) in the treatment of mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen compared to the available alternatives, in particular chemotherapy, despite the fact that a comparative study was possible,
• the toxicity marked by an incidence of serious adverse events (AEs) reported in a third of patients (34%) and of grade ≥ 3 adverse events in almost one in two patients (48.1%).

The Transparency Committee considers that, on the basis of currently available data, JEMPERLI (dostarlimab) has no role in the care pathway.

It considers that in a context in which no robust comparative data is available to guarantee the solidity of the conclusion with respect to the effect of treatment with JEMPERLI (dostarlimab), the introduction of this medicinal product into the care pathway is accompanied by a higher risk than for medicinal products for which the efficacy is based on a comparison conducted with control of the risk of wrongly concluding that the treatment is effective (two-tailed alpha risk conventionally accepted to be 5%).