In July of 2023, the Oncology Society of the Chinese Medical Association unveiled the "Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2023 Edition)" (the “Guidelines”). These Guidelines have highlighted the recommendations for the usage of COSELA® (trilaciclib) and Endostar® (recombinant human endostatin)—two innovative anti-tumor drugs offered by Simcere Zaiming in China.
In the section focusing on "First-line treatment of patients with extensive-stage small cell lung cancer (SCLC)," the Guidelines suggest the preventive administration of COSELA® before chemotherapy to decrease the occurrence of chemotherapy-induced myelosuppression (supported by Class 1 recommendation evidence)[1].
Analysis combining data from three clinical studies reveals that [2], when compared to the control group, the use of COSELA® significantly lessened severe neutropenia in SCLC patients (11.4% vs. 52.9%, P<0.0001), as well as febrile neutropenia (FN) (3.3% vs. 9.2%, P=0.089), grade 3/4 anemia (20.3% vs. 31.9%, P=0.028), and grade 3/4 thrombocytopenia (19.5% vs. 36.1%, P=0.0067). This demonstrates a multi-lineage myeloprotective effect.
In the "Treatment of stage IV non-small cell lung cancer (NSCLC)" section, Endostar® is recommended for the use alongside chemotherapies as a first-line treatment and maintenance therapy (supported by Class 1 or 2A recommendation evidence).
The results from a randomized, double-blind, placebo-controlled study involving previously untreated, advanced NSCLC patients indicate that [3], when compared to the paclitaxel and carboplatin (TC) regimen, the combination of Endostar® with TC regimen yielded improved clinical efficacy and survival benefits: the objective response rate (ORR) for the treatment group and control group were 39.3% and 23.0% (P=0.078), respectively, and the disease control rate (DCR) was 90.2% and 67.2% (P=0.004); median progression-free survival (PFS) was 7.1 months and 6.3 months (p=0.522), with 24-week PFS rates at 78% and 59%, respectively (p=0.017). Median overall survival (OS) was 17.6 months vs. 15.8 months (p=0.696)[3]. Importantly, the safety analysis showed no notable difference in adverse events or serious adverse events between the two groups, and no increase in chemotherapy-related toxicity or side effects was observed with the Endostar® combined TC regimen.
Currently, COSELA®, available in both the US and China, has been incorporated into four global guidelines and expert consensuses. Furthermore, Endostar®, an innovative biologic introduced in China over a decade ago, has received recommendations from 20 authoritative Chinese clinical guidelines, expert consensuses, and clinical norms.
Lung cancer stands as a significant contributor to the worldwide cancer incidence and mortality. Simcere Zaiming, collaborating with global researchers and clinical experts, remains committed to the fight against cancer. Guided by the evidence-based clinical guidelines, COSELA® and Endostar® are poised to increasingly play an extensive and impactful role in the treatment of lung cancer, ultimately benefiting a larger number of patients.
References：
1. Oncology Society of Chinese Medical Association; Chinese Medical Association Publishing House. [Oncology Society of Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2023 edition)]. Zhonghua Zhong Liu Za Zhi. 2023, 45(7): 539-574.
2. Weiss JM, Csoszi T, Maglakelidze M, et al. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small‐cell lung cancer receiving first‐line chemotherapy: a phase Ib/randomized phase II trial[J].Ann Oncol, 2019, 30(10): 1613‐1621.
3. Han B, Xiu Q, Wang H, et al. A multicenter, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy of paclitaxel‐carboplatin alone or with endostarfor advanced non‐small cell lung cancer[J]. J Thorac Oncol, 2011, 6(6): 1104‐1109.