Merck's Keytruda Shows Positive Phase 3 Results in First-Line Treatment of Triple-Negative Breast Cancer and Stage III Non-Small Cell Lung Cancer

Today, MSD announced that its blockbuster PD-1 inhibitor, Keytruda, achieved positive results in Phase 3 clinical trials for the treatment of triple-negative breast cancer and Stage III non-small cell lung cancer (NSCLC). Keytruda has already been approved for more than 20 indications. These latest findings raise hopes that this major cancer immunotherapy will benefit a broader population of cancer patients. Detailed results from these clinical trials will be presented at the upcoming ASCO Annual Meeting at the end of the month.

Triple-Negative Breast Cancer

In the Phase 3 KEYNOTE-355 clinical trial, Keytruda in combination with chemotherapy was used as first-line treatment for patients with metastatic triple-negative breast cancer. The trial results demonstrated that in patients with a PD-L1 Combined Positive Score (CPS) >10, the combination of Keytruda and chemotherapy significantly improved progression-free survival (PFS). Compared with chemotherapy alone, the combination therapy reduced the risk of disease progression or death by 35% (HR=0.65, 95% CI, 0.49–0.86; p=0.0012). The median PFS for patients receiving the Keytruda combination regimen was 9.7 months, compared with 5.6 months in the chemotherapy group.

In patients with CPS > 1, Keytruda in combination with chemotherapy improved PFS from 5.6 months to 7.6 months compared with chemotherapy alone (HR=0.74, 95% CI, 0.61-0.90, p=0.0014).

This study will continue to evaluate the overall survival endpoint in patients.

Stage III Non-Small Cell Lung Cancer

In the Phase 2 clinical trial named KEYNOTE-799, Keytruda was used in combination with chemoradiotherapy (CCRT) to treat patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). The trial results demonstrated that in the cohort of patients with squamous and non-squamous NSCLC who concurrently received paclitaxel plus carboplatin, the combination therapy of Keytruda and CCRT achieved an objective response rate (ORR) of 67.0%. In the cohort of patients with non-squamous NSCLC who concurrently received cisplatin and pemetrexed, the Keytruda-based combination therapy achieved an ORR of 56.6%.

Moreover, the final analysis of data from the pivotal Phase 3 KEYNOTE-189 clinical trial demonstrated that 45.7% of patients with metastatic non-squamous NSCLC who received Keytruda in combination with chemotherapy were still alive two years after treatment initiation, compared with 27.3% of those who received chemotherapy alone. These results highlight the long-term efficacy of Keytruda.

References:

[1] New Combination Data for Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Clinical Benefit in Stage III Non-Small Cell Lung Cancer (NSCLC) and Reinforce Long-Term Survival in Metastatic NSCLC. Retrieved May 13, 2020, from https://www.mrknewsroom.com/news-release/oncology/new-combination-data-mercks-keytruda-pembrolizumab-demonstrated-clinical-benef

[2] Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Chemotherapy in Certain Patients with Metastatic Triple-Negative Breast Cancer. Retrieved May 13, 2020, from https://www.mrknewsroom.com/news-release/oncology/mercks-keytruda-pembrolizumab-plus-chemotherapy-demonstrated-statistically-sig

Original Title: Keytruda Reports Frequent Successes: Positive Phase 3 Clinical Results for First-Line Treatment of Triple-Negative Breast Cancer and Early-Stage Non-Small Cell Lung Cancer

▽Follow [WuXi AppTecMerck】WeChat Official Account