NICE Approves Merck’s Keytruda for Adult Patients with Triple-Negative Breast Cancer

Compiled by | Li Tom

Recently, the National Institute for Health and Care Excellence (NICE) in the UK announced the recommendation of MSD's Keytruda therapy for the treatment of adult patients with rare triple-negative breast cancer.

The UK NICE Independent Expert Evaluation Committee unanimously agreed that the Keytruda combination therapy achieved the cost-effectiveness threshold for life-extending treatments in patients with shorter life expectancies. It is estimated that approximately 100 patients with triple-negative breast cancer may benefit annually from the Keytruda therapy. Relevant evidence from clinical trials also indicates that, compared to other available treatments, the combination of Keytruda and chemotherapy can increase patient life expectancy and delay the progression of cancer.

The recent recommendation issued by NICE in the UK also implies that patients who were previously ineligible for treatment with atezolizumab combined with chemotherapy may now qualify for treatment with Keytruda. Patients receiving Keytruda therapy need to be administered an injection every three weeks. Keytruda, also known as pembrolizumab, has been recommended for adult patients with metastatic disease who have not received chemotherapy and whose tumors cannot be surgically removed.

Helen Knight, interim director of NICE's drug evaluation in the UK, commented that patients who are unable to use atezolizumab, another immunotherapy recommended by NICE in the UK, now have an additional treatment option that can help them live longer and spend more precious time with their loved ones.

It is worth noting that the approval process for "MSD's Keytruda in the treatment of triple-negative breast cancer" has not been smooth sailing. As early as March this year, NICE issued a draft guideline rejecting the approval of MSD's anti-PD-1 therapy Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC). (For details, click on "Treatment for Triple-Negative Breast Cancer: MSD's Keytruda Rejected by UK NICE》）

At that time, in the draft guidelines, the agency stated that while the combination of Keytruda and chemotherapy was more effective than chemotherapy alone, its long-term benefits were still uncertain. Additionally, there was no comparative data available between the Keytruda + chemotherapy combination and Roche's anti-PD-L1 therapy Tecentriq (atezolizumab) + chemotherapy combination. The latter was recommended by NICE for use in the UK National Health Service (NHS) in May 2020 to treat patients with mTNBC.

Subsequently, MSD said in a statement that it was disappointed with the NICE draft guidance but would work with NICE to try to find a way for patients to access Keytruda. Now, the matter has finally been temporarily resolved.

In fact, Keytruda has been attracting attention since its approval for marketing in 2014. This重磅 tumor immunotherapy has shown promising efficacy in various cancers and can be comprehensively used to treat melanoma, head and neck cancer, non-small cell lung cancer, classical Hodgkin lymphoma, bladder cancer, stomach cancer, etc. In 2021, the sales of this drug reached 17.18 billion US dollars.

Keytruda therapy primarily works by blocking the activity of a protein called PD-L1, which is produced in higher quantities on cancer cells than on normal cells. By blocking this protein, Keytruda therapy allows the patient's own immune cells to attack tumor cells within the body.

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NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer