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The first-line treatment of three-generation EGFR-TKI vometinib reached the end point of the trial; two marketing applications of terepliumab were qualified for FDA priority review 丨 Tumor Intelligence

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The first-line treatment of three-generation EGFR-TKI vometinib reached the end point of the trial; two marketing applications of terepliumab were qualified for FDA priority review 丨 Tumor Intelligence

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Important points

Gastric Cancer: CEA and CA 19-9 are independent prognostic factors in the postoperative period in patients with gastric cancer

CCR: The multi-target inhibitor cabozantinib may bring new hope to STS patients

New drugs: first-line treatment of NSCLC, three-generation EGFR-TKI vometinib phase III clinical endpoints

New drugs: Two marketing applications for triprimizumab were qualified for FDA priority review

01 Gastric Cancer: CEA and CA 19-9 are independent prognostic factors in patients with gastric cancer

The investigators conducted a post-mortem analysis of the CRITICS trial to evaluate the prognostic value of tumor markers in the European cohort of resectable gastric cancer patients. The results showed that carcinoembryonic antigen (CEA) and CA 19-9 were independent prognostic factors, and no relationship between tumor markers and ctDNA was found. These factors may guide treatment options and should be included in future trials to determine their definitive location.

The first-line treatment of three-generation EGFR-TKI vometinib reached the end point of the trial; two marketing applications of terepliumab were qualified for FDA priority review 丨 Tumor Intelligence

Screenshot of the official website

The results of the multivariate analysis of this study showed that elevated pre-treatment CEA (HR 1.43; 95% CI 1.11–1.85, p< 0.001) and CA 19-9 (HR 1.79; 95% CI 1.42–2.25, p<0.001) were associated with poorer OS. Patients with no elevated tumor markers, elevated CEA or CA 19-9, and elevated both are 86%, 77%, and 60% likely to undergo potential radical surgery (p<0.001, respectively). Although the presence of preoperative ctDNA and tumor markers are both prognostic factors for survival, no correlation was found between these two parameters.

02 CCR: The multi-target inhibitor cabozantinib may bring new hope to STS patients

Soft tissue sarcoma (STS) is a rare group of heterogeneous mesenchymal tissue tumors. For decades, the mainstay of treatment for advanced, unresectable STS has been palliative chemotherapy. The multi-receptor tyrosine kinase inhibitor cabotinib dual-targeting VEGF and MET pathways may yield clinical benefit in STS populations. The results of this Phase II clinical trial showed that the monothetic antitumor activity of cabotinib was observed in patients with selected HIST subtypes of STS (acinar soft tissue sarcoma, undifferentiated polymorphic sarcoma, extraoskeletal mucoid chondrosarcoma and leiomyosarcoma), highlighting the biomolecular diversity of STS.

The first-line treatment of three-generation EGFR-TKI vometinib reached the end point of the trial; two marketing applications of terepliumab were qualified for FDA priority review 丨 Tumor Intelligence

The researchers conducted an open-label, multi-institutional, single-arm phase II trial of cabozantinib monotherapy in adults with advanced STS who developed disease progression after at least first-line standard systemic therapy. Patients received 60 mg of oral cabotinib once daily in a 28-day cycle and assessed dual primary endpoints of overall response rate and 6-month progression-free survival (PFS).

The results showed that 6 of the 54 evaluable patients enrolled in the group (11.1%, 95% CI: 4.2% to 22.6%) had an objective response (all partial responses). The 6-month PFS was 49.3% (95% CI: 36.2%-67.3%), with a median study duration of 4 cycles (range: 1-99). The most common grade 3/4 adverse events were hypertension (7.4%) and neutropenia (16.7%). Regardless of clinical outcome, patients with circulating HGF, soluble MET, and VEGF-A levels are usually elevated after a cycle of treatment, while soluble VEGFR2 levels are decreased.

03 New drugs: first-line treatment of NSCLC, three-generation EGFR-TKI vometinib phase III clinical primary endpoint

On 1 November, Ellis Pharma announced that its third-generation EGFR-TKI drug Ephrosa (vometinib mesylate) was a multicenter, randomized controlled, double-blind Phase III clinical study (FURLONG) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, achieving the primary endpoint of PFS: Vometinib treatment group showed a statistically significant and clinically significant PFS benefit compared to the control group treated with a generation EGFR-TKI. The specific data results of the study will be officially published at future international academic conferences.

04 New drugs: Two marketing applications for triprimizumab were qualified for FDA priority review

On October 31, Junshi Biotech announced that the U.S. Food and Drug Administration (FDA) has accepted applications for the licensing of biological products (BLA) for two indications for nasopharyngeal carcinoma with tripramine monoclonal antibody, namely: the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma with gemcitabine/cisplatin, and the single drug for second-line and above treatment after platinum-containing treatment for recurrent or metastatic nasopharyngeal carcinoma.

bibliography:

[1] Slagter, A.E., Vollebergh, M.A., Caspers, I.A. et al. Prognostic value of tumor markers and ctDNA in patients with resectable gastric cancer receiving perioperative treatment: results from the CRITICS trial. Gastric Cancer (2021). https://doi.org/10.1007/s10120-021-01258-6

[2] Geraldine O'Sullivan Coyne, Shivaani Kummar, James Hu et al. Clinical activity of single-agent cabozantinib (XL184), a multi-receptor tyrosine kinase inhibitor, in patients with refractory soft tissue sarcomas. DOI:10.1158/1078-0432.CCR-21-2480

[3]https://mp.weixin.qq.com/s/OasIg8lFjOItxvLhGSvT3A

[4]https://mp.weixin.qq.com/s/6QcbHxJiGIBOegGsy_vuXA

This article was first published: Medical Oncology Channel

Author: Tumor Intelligence Unit

This article was reviewed: Yu Jiangyong Beijing Hospital

Editor-in-Charge: Sweet

Copyright Statement

Original article If you need to reprint, please contact the authorization

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The first-line treatment of three-generation EGFR-TKI vometinib reached the end point of the trial; two marketing applications of terepliumab were qualified for FDA priority review 丨 Tumor Intelligence