'Expanded reimb for Keytruda…expected to improve solid cancer treatment performance'

Reimbursement for 11 indications, including triple-negative breast cancer and endometrial cancer

Expansion includes major cancers with high unmet needs…improved overall treatment access

Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang Hospital

The immune checkpoint inhibitor Keytruda is bringing a major shift in the oncology treatment landscape in Korea following expanded scope of reimbursement across major solid tumors.

Of the 11 indications included in the reimbursement scope, evaluations suggest that the potential to improve patient access and survival outcomes has increased in areas where existing treatment options were limited.

On the 29th, MSD Korea held a press conference at Seongam Art Hall in Gangnam-gu, Seoul, to commemorate the expansion of reimbursement for Keytruda (pembrolizumab).

Starting from the 1st of this month, Keytruda's reimbursement in Korea has been expanded to a total of 11 indications, including metastatic HER2-positive and negative gastric cancer, recurrent and metastatic triple-negative breast cancer (TNBC), head and neck cancer, and endometrial cancer.

As MSD's flagship immunotherapy targeting PD-1, Keytruda has proven clinical evidence across various solid tumors, and this reimbursement adjustment is drawing industry attention as it covers cancers with high unmet medical needs.

Professor Keun-Wook Lee of the Department of Hematology and Oncology at Seoul National University Bundang Hospital emphasized the importance of expanding Keytruda's reimbursement for gastrointestinal cancers, including gastric and colorectal cancers.

Patient access to Keytruda has improved, as reimbursement is now available for major gastrointestinal cancers, including HER2-positive gastric cancer, first-line treatment for HER2-negative gastric cancer with PD-L1 CPS 10 or higher, and microsatellite instability-high (MSI-H) colorectal cancer.

​Professor Lee evaluated, "Keytruda's accessibility has improved as it is now reimbursed for major gastrointestinal cancers," and added, "Considering the characteristics of these cancers, which are directly linked to eating, digestion, and bowel functions and cause great discomfort in life, this expansion is a crucial turning point for patients."

Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance Hospital

Professor Lee added, "Reimbursement to minority patient groups such as MSI-H is a meaningful achievement from both clinical and institutional perspectives."

Professor Min Hwan Kim of the Department of Hematology and Oncology at Severance Hospital mentioned major clinical evidence in female cancers, such as breast and endometrial cancer.

Professor Kim stated, "Keytruda demonstrated meaningful therapeutic effects in metastatic endometrial cancer for the first time in about 50 years, and clearly showed improvement in survival duration compared to conventional therapies even in triple-negative breast cancer, which has a very poor prognosis."

Professor Kim explained, "Keytruda confirmed meaningful treatment outcomes in metastatic settings based on sustained responses, which can lead to prolonged survival and improved quality of life."

​Beyond immunotherapy toward ADCs and targeted therapies, MSD's R&D strategy is accelerating

Immune checkpoint inhibitor to ADC and targeted cancer drug

Soo Jung Kim, Executive Director of the Medical Affairs Department at MSD Korea

MSD Korea is strengthening domestic access to cancer treatment and developing innovative new drugs, starting with this reimbursement expansion.

MSD is also making efforts to improve administration convenience by developing a subcutaneous (SC) formulation of Keytruda, named 'Keytruda QLEX.'

Soo Jung Kim, Executive Director of the Medical Affairs Department at MSD Korea, said, "Keytruda holds more than 40 indications across 18 cancer types. It has changed the paradigm of cancer treatment by improving survival duration in various cancers," and noted, "In the case of Keytruda QLEX, administration is possible in just two minutes. This will significantly increase patient convenience."

Kim added, "More than 30 global Phase 3 clinical trials for new oncology drugs are underway. We are expanding our R&D portfolio not only in immunotherapy but also in the fields of targeted therapy and antibody-drug conjugates (ADC)."

MSD entered into a joint ADC development agreement with Daiichi Sankyo in 2023 and secured global rights (excluding Japan) for three candidate materials ▲patritumab deruxtecan ▲ifinatamab deruxtecan ▲raludotatug deruxtecan.

In particular, clinical research on the B7-H3-targeting ADC 'ifinatamab deruxtecan' is underway to establish a new combination for small cell lung cancer through combination strategies with MSD's bispecific antibody 'MK-6070.'

MSD is also conducting global Phase 3 trials for the ADC 'MK-2870.' MK-2870 targets Trop-2 and is being developed with the goal of securing an indication for triple-negative breast cancer. This ADC is a candidate material that MSD in-licensed from China's Kelun-Biotech in 2022 for $1.41 billion.

MSD is also actively pursuing next-generation combination strategies linking immunotherapies, targeted therapies, and cancer vaccines.

Albert Kim, CEO of MSD Korea, said, "Keytruda's expanded reimbursement is the result of everyone's cooperation to create a healthy tomorrow for patients," and added, "We will continue to prioritize patient-centered treatment accessibility as our top value and actively participate in creating clinical evidence and discussions."