dm+d

Unassigned

Refrigerated Storage

JemperliGSK

GSK
Jemperli
500mg concentrate for solution for infusion

In the event of an inadvertent temperature excursion the following data may be used:
The product is stable when exposed to a single temperature excursion of up to 30°C for up to 40 hours.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No
7 October 2022
London MI Service

New Medicines

JemperliAdvanced recurrent microsatellite instability-high (MSI-H) mismatch repair deficiency (dMMR) endometrial cancer

Information

Jemperli
New molecular entity
GlaxoSmithKline
Tesaro

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
July 2021
Jul 21Jemperli 500mg/10ml concentrate for solution for infusion available in the UK. Price for 1 vial = £5887.33 [12].
Jun 21Approved in UK [10]
Apr 21Approved in EU [9]
Apr 21Approved in US [8]
Feb 21Recommended for EU conditional approval by CHMP - the full indication is "as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen." It must be initiated and supervised by specialist physicians experienced in the treatment of cancer [7]. Conditional approval indicates that the information available is less than would usually be required, but that the medicine fulfils a significant unmet need and the benefit to risk balance is considered to be acceptable under those circumstances; the manufacturer will normally be expected to provide further clinical data to retain the marketing authorisation.
Aug 20EMA is no longer reviewing NDA under the accelerated assessment programme [5].
Apr 20EMA accepts NDA for accelerated assessment [4].
Feb 20Has been filed to the regulatory authorities; presumably EU & US [3].

Category

Humanised anti-programmed death-1 (PD-1) monoclonal antibody. Planned dose is 500mg every three weeks for 4 cycles followed by 1000mg every six weeks
In the UK there are about 8,600 new cases per year [1].
Advanced recurrent microsatellite instability-high (MSI-H) mismatch repair deficiency (dMMR) endometrial cancer
Intravenous infusion

Further information

Yes

Trial or other data

Jun 20PI GARNET study is recruiting and now due to complete collection of primary outcome data in Nov 23 [6].
Jan 20PI GARNET study is recruiting [2].
Mar 16PI first-in-human GARNET study to the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) in patients with advanced solid tumors who have limited available treatment options starts (NCT02715284). The study will be conducted in 2 parts: dose escalation and cohort expansion. The cohort expansion may include various tumor types, including endometrial, Non-Small Cell Lung cancer, and non-endometrial deficient mismatch repair (dMMR)/microsatellite instability-high (MSI-H) solid tumors. 740 adults will be recruited in countries including the US, EU & UK. Collection of primary outcome data is due to complete Dec 21 [2].

Evidence based evaluations

SMC

JemperliRecurrent or primary advanced (stage III or IV) endometrial cancer - add-on to standard of care (carboplatin-paclitaxel)

Information

Jemperli
Licence extension / variation
GlaxoSmithKline
Tesaro

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Humanised anti-programmed death-1 (PD-1) monoclonal antibody. Planned dose is 500mg every three weeks for 4 cycles followed by 1000mg every six weeks
In the UK there are about 8,600 new cases per year [1].
Recurrent or primary advanced (stage III or IV) endometrial cancer - add-on to standard of care (carboplatin-paclitaxel)
Intravenous

Further information

Yes

Evidence based evaluations

JemperliStage III or IV ovarian cancer - first-line with chemotherapy, followed by combination with niraparib as maintenance

Information

Jemperli
Licence extension / variation
GlaxoSmithKline
Tesaro

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Humanised anti-programmed death-1 (PD-1) monoclonal antibody. Proposed dose is 500mg every three weeks for 5 cycles (in combination with carboplatin and paclitaxol) followed by a maintenance phase using 1,000 mg every 6 weeks for all cycles thereafter (in combination with niraparib).
There are around 7,400 new ovarian cancer cases in the UK every year. Incidence rates for ovarian cancer in the UK are highest in females aged 75 to 79. Almost 6 in 10 ovarian cancer cases are diagnosed at a late stage. Incidence rates for ovarian cancer have been projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035 [1].
Stage III or IV ovarian cancer - first-line with chemotherapy, followed by combination with niraparib as maintenance
Intravenous