Reimb in progress for 1st endometrial cancer immunotherapy

Will the drug change the market landscape ?

Approved as a second-line treatment for endometrial cancer with specific biomarker

Lacked a new drug option for decades...effect improved with the introduction of a cancer immunotherapy

Jemperli attempts reimb this year...” urgent need for rapid reimbursement”

Pic of Jemperli

Will the latecomer cancer immunotherapy ‘Jemperli (dostarlimab)’ from GSK be reimbursed as the first cancer immunotherapy in endometrial cancer?

 

With cancer immunotherapies changing the treatment paradigm for the first time in decades, the demand in the field to speed up the reimbursement progress has also been increasing.

 

in the field.

 

According to industry sources on the 30th, GSK has applied for the reimbursement of Jemperli to the Health Insurance Review and Assessment Service and is awaiting the application to be deliberated by the Cancer Disease Deliberation Committee.

 

Therefore, whether the agenda will be deliberated by the CDDC is receiving attention.

 

Jemperli is the 7th approved cancer immunotherapy in Korea.

 

The drug received marketing authorization from the Ministry of Food and Drug Safety in December last year.

 

The drug is a PD-1 inhibitor like Keytruda and Opdivo.

 

Unlike the other PD-1 immunotherapies, Jemperli was first approved for use as a second-line treatment in patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen who have a specific biomarker.

 

The biomarker approved in the indication is ‘microsatellite instability-high or mismatch repair deficient (dMMR).' As a latecomer in the cancer immunotherapy market, Jemperli sought to clearly distinguish itself from the other drugs.

 

Its strategy was to solidify its position in endometrial cancer, an area that has almost no existing immuno-oncology drugs in the market.

 

In fact, only Keytruda among the existing cancer immunotherapy has indications for endometrial cancer.

 

Jemperli entered as the second immuno-oncology drug in the field and started a one-on-one competition with Keytruda.

 

Endometrial cancer is a cancer that occurs in the endometrium, which constitutes the inner wall of the uterus and accounts for the majority of cervical cancers.

 

Approximately 1 out of 4 endometrial cancer patients are diagnosed in the advanced stage or experience recurrence, and there is no effective treatment available if the condition recurs after platinum-based chemotherapy.

 

When using chemotherapy in the second line, the known average survival rate is less than 1 year, and the 5-year survival rate is only 10%.

 

No new treatment has been introduced for relapsed or advanced endometrial cancer for around 30 years.

 

The immunotherapies that have been introduced after decades have been evaluated to have transformed the endometrial cancer treatment paradigm.

 

MSI-H/dMMR, which is considered a major biomarker for endometrial cancer treatment, is known to be present in up to 26% of patients.

 

This is the highest among solid cancers.

 

This means that the use of cancer immunotherapies can be relatively large in the area.

 

Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen.

 

In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far.

 

As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile.

 

In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached.

 

83.7% of the patients that showed response continued treatment for over 2 years.

 

Overall survival (OS) estimates at 12 months and 24 months were 73.3% and 60.5%, respectively.

 

Patients did not reach the median OS even with a long-term follow-up of more than 2 years.

 

Recently, a possibility had risen for expanding the use of cancer immunotherapies as a first-line treatment for recurrent and advanced endometrial cancer.

 

In the first quarter of this year, Jemperli and Keytruda each announced clinical results showing that the drugs were effective when used in combination with chemotherapy in the first line.

 

In the Phase III RUBY study, Jemperli lowered the risk of disease progression and death by 36% compared to the placebo group.

 

This is significant as the trial included patients without MSI-H/dMMR biomarkers.

 

In the MSI-H/dMMR patient group, the risk of disease progression and death decreased by 72%.

 

Keytruda reduced the risk of disease progression and death by 70% in patients with MSI-H/dMMR in a clinical trial.

 

With the performance of cancer immunotherapies gaining prominence and data to change the standard treatment, and chemotherapy, increasing, the demand for the reimbursement of cancer immunotherapies in clinical settings has also been rising.

 

No cancer immunotherapy is currently approved for reimbursement in endometrial cancer yet.

 

In the global market, cancer immunotherapy is already being reimbursed in five of the major A8 countries - the US, Germany, the UK, Switzerland, and Italy.

 

Currently, only Jemperli has applied for reimbursement for endometrial cancer.

 

However, an unmet demand exists as the agenda has not been presented for CDDC review for some while.

 

Seob Jeon, Director of the Insurance Committee at the Korean Society of Gynecologic Oncology (Gynecology, Soonchunhyang University Cheonan), said, “The introduction of a new cancer immunotherapy option that can be used as monotherapy in recurrent endometrial cancer, an area that had a 5-year survival rate below 10%, has brought new hope to the patients.

 

However, we need collaborative efforts from the government and pharmaceutical companies for the patients who are waiting for reimbursement for cancer immunotherapy because they have no other alternative than cytotoxic chemotherapy.

 

I hope that the policy grounds will be laid so that the benefits of the treatment can be applied in the field."