Pembrolizumab Demonstrates Long-Term Survival Benefits Across Multiple Advanced Cancers, Highlighted by First-Ever 5-Year Data of PD-1 Inhibitor Plus Chemotherapy in First-Line Metastatic NSCLC

--The First 5-Year Survival Data of PD-1 Combined with Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer Released Globally

ShanghaiSeptember 22, 2022PR Newswire -- September 14, 2022 -- At the conclusion of the 2022 European Society for Medical Oncology (ESMO) Congress on September 13, long-term five-year survival follow-up data were released for multiple first-line immunotherapy combined with chemotherapy treatments for advanced non-small cell lung cancer (NSCLC). This includes the five-year survival data from two Phase III clinical trials (KEYNOTE-189 and KEYNOTE-407) investigating MSD's PD-1 inhibitor pembrolizumab (commonly known as "K drug" in China) in combination with chemotherapy for the first-line treatment of metastatic non-small cell lung cancer.

Long-term follow-up data analysis results from two studies show that pembrolizumab combined with platinum-based chemotherapy offers better long-term survival rates compared to platinum-based chemotherapy alone. The five-year OS rates for first-line treatment of advanced squamous NSCLC or non-squamous NSCLC were 18.4% and 19.4%, respectively, while those for chemotherapy were 11.3% and 9.7%.^{[1], [2]}。

Between 2012 and 2015, the overall five-year survival rate for lung cancer in China was 19.7%.^[3], where the 5-year survival rate for early-stage (Stage I) lung cancer is 55.47%, but once it metastasizes to Stage IV lung cancer, the 5-year survival rate drops to 5.27%.^[4]In China, most lung cancer patients are already at stage III or IV at the time of initial diagnosis.^[5]Non-small cell lung cancer accounts for 85% of lung cancer cases.

Based on the results of the KEYNOTE-189 and KEYNOTE-407 studies, the China National Medical Products Administration approved pembrolizumab in combination with chemotherapy as a first-line treatment for metastatic squamous and non-squamous non-small cell lung cancer in 2019. This treatment regimen has become the preferred standard of care for this group of patients with advanced lung cancer.

The long-term survival data of patients from KEYNOTE-189 and KEYNOTE-407 released at this year's ESMO has brought confidence in improving the treatment standards for advanced lung cancer patients in China, extending patient survival, and thereby increasing the overall 5-year survival rate for lung cancer in China. This holds profound significance.

Pembrolizumab combined with chemotherapy as a first-line treatment is currently the only PD-1 combined chemotherapy regimen proven to improve the five-year survival rate for metastatic non-small cell lung cancer. In addition to KEYNOTE-189 and KEYNOTE-407, the phase III clinical trial of pembrolizumab monotherapy as a first-line treatment for selected populations with metastatic non-small cell lung cancer has also previously released five-year long-term survival data, including

In China, in addition to the three indications for treating advanced NSCLC, pembrolizumab has also been approved for five other treatment indications, including

Healthy China 2030 proposes the goal of increasing the overall five-year survival rate of tumors by 15 percentage points. The improvement in the five-year survival rate of advanced lung cancer, including the continuous enhancement of the five-year survival rates of various malignant tumors, is clearly a contributing factor to achieving this goal. We look forward to more and longer survival data from clinical studies on the treatment of various malignant tumors with pembrolizumab, continuously striving for the goal of "longer, broader, higher," and bringing more hope to cancer patients in China.

^{[1] M.C. Garassino et al., KEYNOTE-189 5-year update: First-line pembrolizumab (pembro) + pemetrexed (pem) and platinum vs placebo (pbo) + pem and platinum for metastatic nonsquamous NSCLC, 2022 ESMO, Abs #973MO
[2] S. Novello et al., 5-year update from KEYNOTE-407: Pembrolizumab plus chemotherapy in squamous non-small cell lung cancer (NSCLC)， 2022 ESMO，Abs # 974MO
[3] Zeng HM，ChenWQ，Zheng RS，et al. Changing cancer survival in China during 2003-15：a pooled analysis of 17 population-based cancer registries[J].Lancet Glob Health，2018，6(5):e555-e567.DOI:10.1016/S2214-109X(18)30127-X.
[4] ZHANG Minlu, WU Chunxiao, GONG Yangming, et al. Analysis of lung cancer survival rate in Shanghai population [J]. China Cancer, 2017, 27(5): 326-333. DOI: 10.19401/j.cnki.1007-3639.2017.05.002.
[5] Shi JF，Wang L，Wu N，et al. Clinical characteristics and medical service utilization of lung cancer in China,2005-2014:overall design and results from a multicenter retrospective epidemiologic survey[J]. Lung Cancer, 2019, 128:91-100.DOI:10.1016/j.lungean.2018.11.031.
[6] Martin Reck et al., Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50 J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.
[7] Results 1274 patients were randomized to pembrolizumab or chemotherapy (n = 637 each). Median (range) time from randomization to data cutoff (Apr 28, 2021) was 61.1 (50.0–76.3) months.
[8] Metges JP et al., FIrst-line Pembrolizumab Plus Chemotherapy Versus Chemotherapy in Advanced Esophageal Cancer: Longer-term Efficacy, Safety, and Quality-of-life Results From the Phase 3 KEYNOTE-590 Study, 2022 ASCO-GI, Oral Presentation
[9] M. Tahara et al., Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048 2022 ESMO, Abs #659MO
[10] Pembrolizumab Injection Instructions, 2021
[11] Caroline Robert et al., Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 studyLancet Oncol. 2019 Sep;20(9):1239-1251. doi: 10.1016/S1470-2045(19)30388-2. Epub 2019 Jul 22.}