Merck Keytruda: Strong efficacy in treating melanoma at all stages!

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Merck Keytruda: Strong efficacy in treating melanoma at all stages!

Melanoma immunotherapy! Merck’s Keytruda has shown strong efficacy in treating melanoma at all stages!

Many patients with stage II melanoma have a high risk of recurrence after surgery.

Merck recently announced new data on the evaluation of anti-PD-1 therapy Keytruda (pembrolizumab, pembrolizumab) for the treatment of melanoma at the 2021 conference of the Society for Melanoma Research (SMR) , Including:

(1) KEYNOTE-006 trial (NCT01866319) exploratory 7-year follow-up data, which is a key trial supporting Keytruda for the treatment of advanced melanoma indications;

(2) the latest findings of the KEYNOTE-716 trial (NCT03553836), the trial Evaluation of Keytruda adjuvant treatment of adult and pediatric (12 years and older) patients after complete resection of stage IIB or IIC melanoma .

1. KEYOTE-587 trial data: exploratory 7-year follow-up of patients in the KEYNOTE-006 trial

KEYNOTE-006 is an open-label, randomized, phase 3 study that compares Keytruda with Bristol-Myers Squibb tumor immunotherapy CTLA-4 inhibitor Yervoy (Chinese trade name: Yiwo, generic name: ipilimumab, ipilimumab/ Ipilimumab) for the efficacy and safety of patients with advanced melanoma .

After the KEYNOTE-006 trial ends, patients are eligible to transition to the KEYNOTE-587 trial for extended follow-up. A 7-year follow-up evaluation of 210 patients in the KEYNOTE-006 trial (158 patients treated with Keytruda and 52 patients treated with Yervoy).

Long-term follow-up results showed that the median overall survival (OS) of the Keytruda group was 32.7 months, and that of the Yervoy group was 15.9 months (HR=0.70; [95%CI:0.58-0.83]). The 7-year survival rates of the Keytruda group and Yervoy group were 37.8% and 25.3%, respectively. The results of this exploratory analysis showed that regardless of BRAF status, previous BRAF inhibitor (BRAFi) treatment, poor prognostic characteristics (for example, high LDH levels, large tumor size, presence of brain metastases, etc.), Keytruda is consistent with improved clinical The results are relevant.

These results represent the longest follow-up time for a Phase 3 trial of anti-PD-1/L1 treatment of advanced melanoma to date. There are no plans to conduct a formal statistical test of the data.

2. KEYOTE-716 test data

KEYNOTE-716 is a multicenter , randomized, double-blind phase 3 clinical trial that is comparing the efficacy and safety of Keytruda and placebo in adjuvant treatment of stage IIB or IIC melanoma after complete resection of adult and pediatric (12 years and older) patients sex. The primary endpoint of the trial is recurrence-free survival (RFS).

In the second interim analysis (IA2) prescribed by the protocol, Keytruda adjuvant therapy continued to show clinically significant improvement in RFS compared with placebo, and the risk of disease recurrence or death was reduced by 39% (HR=0.61[95%CI: 0.45 -0.82]). As mentioned earlier, the KEYNOTE-716 trial reached the primary endpoint of RFS in the first interim analysis (HR=0.65[95%CI:0.46-0.92]; p=0.00658), therefore, no statistical test was performed in IA2 . No new safety signals were observed.

At IA2, 14.8% (n=72/487) of patients treated with Keytruda relapsed or died, while 23.5% of patients treated with placebo (n=115/489). At the time of this analysis, the median RFS of the two groups did not reach. The remote recurrence rate of patients in the placebo group (12.3%[n=60/489]) was twice that of patients in the Keytruda group (6.4%[n=31/487]).

At the time of IA2, Keytruda’s security features were consistent with previous reports. Treatment-related adverse events occurred in 82.8% (n=400/483) and 63.4% (n=308/486) in the Keytruda treatment group and placebo group, respectively, 17.0% (n=82/483) and 4.3% (n =21/486) patients had grade 3-4 adverse events, 10.1% (n=49/483) and 1.2% (n=6/486) of patients had grade 3-4 immune-mediated adverse events and Infusion reaction.

Based on the data from the Phase 3 KEYNOTE-716 trial, the US FDA accepted a supplementary biological product license application (sBLA) from Keytruda in early August this year for the adjuvant treatment of adults and pediatrics after complete resection of stage IIB or IIC melanoma (12 Years and older) patients. The FDA has granted priority review to the sBLA and designated the Prescription Drug User Fees Act (PDUFA) as a target date of December 4, 2021.

Many patients with stage II melanoma have a high risk of recurrence after surgery. KEYNOTE-716 is the first phase 3 study that specifically evaluates adjuvant therapy for stage IIB and IIC melanoma, an area with high unmet medical needs. By advancing Keytruda immunotherapy to the early stages of melanoma , after complete surgical resection, Keytruda has the opportunity to reduce the risk of recurrence in high-risk stage II patients compared with observation alone.

Melanoma is the most serious form of skin cancer and is characterized by uncontrolled growth of pigment-producing cells. In the past few decades, the incidence of melanoma has been on the rise. In 2020, there will be nearly 325,000 newly diagnosed cases worldwide. In the United States, skin cancer is one of the most commonly diagnosed cancers, and melanoma accounts for the vast majority of skin cancer deaths. It is estimated that in 2021, the United States will have more than 106,000 cases of new diagnosis of melanoma cases, more than 7,000 will die from the disease.

Keytruda belongs to anti-PD-(L)1 tumor immunotherapy. This type of therapy helps detect and fight tumor cells by improving the ability of the human immune system. Keytruda is an anti-PD-1 therapy that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes that may affect tumor cells and healthy cells. At present, Keytruda has become the basic therapy for many types of cancer.

Regarding the treatment of melanoma, according to the results of the EORTC132/KEYNOTE-054 trial, Keytruda has been approved in more than 90 countries around the world and has been identified as an important treatment option for the adjuvant treatment of patients with high-risk stage III melanoma. In addition, Keytruda is also approved for the treatment of patients with unresectable or metastatic melanoma .

Reference：

New Research for KEYTRUDA (pembrolizumab) at Society for Melanoma Research (SMR) 2021 Congress Reinforces Merck’s Commitment to Patients With Melanoma Across Stages of Disease

Merck Keytruda: Strong efficacy in treating melanoma at all stages!

(source:internet, reference only)

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