Abstract 521P
Background
First-line single-agent immune checkpoint inhibitors are almost ineffective in patients (pts) with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). We hope to improve the therapeutic effect by adding immunotherapy to anti-angiogenic therapy combined with chemotherapy in patients with RAS mutations.
Methods
After statistical consideration, increasing the objective response rate (ORR) from 47% to 65% requires enrolling 52 patients. Primary endpoint is ORR of the combination. The treatment combination is applied every 3 weeks as a cycle: Tislelizumab, 200mg, iv, d1; Bevacizumab, 7.5mg/kg, iv, d1; Oxaliplatin, 130mg/㎡, iv, d1; Capecitabine, 1000mg/㎡, bid, po, d1-d14.
Results
As of February 28, 2024, 52 pts were enrolled. The clinical characteristics were shown in the table. Treatment-related adverse events (TRAEs) of any grade occurred in 43 (82.7%) pts. TRAEs of grade ≥ 3 were mainly myelosuppression (5 pts, 9.6%) and Rash (3 pts, 5.8%). There were no fatal TRAEs. ORR was 69.2% (95% CI: 56.3%, 82.2%), Disease control rate (DCR) was 98.1% (95% CI: 94.2%, 100.0%). Until now, no evidence of disease (NED) rate was 15.4% (8 pts, 95% CI: 5.2%, 25.5%). With median follow-up of 8.3 months, 15 pts had progressive disease, median progression free survival (PFS) and overall survival (OS) are not yet mature. Detection biomarkers of drug activity is in progress. Table: 521P
Clinical characteristics
| Variable | N=52 | Variable | N=52 |
| Age(range) | 59(28, 78) | | KRAS G12D | 14(26.9) |
| Sex, n(%) | | KRAS G12C | 2 (3.8) | |
| | Male | 27(51.9) | | KRAS G12S | 1 (1.9) |
| | Female | 25(48.1) | | KRAS G13D | 13(25.0) |
| ECOG-PS, n(%) | | NRAS | 4 (7.7) | |
| | 1 | 46(88.5) | | Others | 6 (11.5) |
| | 0 | 6 (11.5) | Metastasis site, n(%) | |
| Primary site, n(%) | | Liver | 36(69.2) | |
| | Right Colon | 11(21.2) | | Lung | 16(30.8) |
| | Left Colon | 25(48.1) | | Distant lymph nodes | 11(21.2) |
| | Rectum | 16(30.7) | | Peritoneum | 4 (7.7) |
| TMB(range), n(%) | 5 (1.6, 330) | | Others | 8 (15.4) |
| | ≥ 10 | 7 (13.5) | Metastasis number, n(%) | |
| ConclusionsThe study met primary endpoint. The efficacy of the regimen is promising with well tolerance. Clinical trial identificationNCT05970302. Editorial acknowledgementLegal entity responsible for the studyLin Yang. FundingBeiGene Ltd. DisclosureAll authors have declared no conflicts of interest. Resources from the same session423P - Marginalization and factors associated with early mortality among patients diagnosed with de novo metastatic breast cancer in Ontario, CanadaPresenter: Priya Thomas Session: Poster session 15 425P - The humanitarian PACT for advanced breast cancer: A multi-stakeholder collaboration to improve access to treatment in low- and middle-income countriesPresenter: Alicia Annamalay Session: Poster session 15 426P - Impact of statin therapy on mortality and recurrence in female breast cancer: A meta-analysisPresenter: Maria Eduarda Souza Session: Poster session 15 427P - The role of patient navigation (PN) in delivering goal-concordant care to advanced breast cancer (ABC) patientsPresenter: Akshara Singareeka Raghavendra Session: Poster session 15 428P - Key landmarks of male advanced breast cancer: Results of the GEICAM/2016-04 studyPresenter: Noelia Martinez Session: Poster session 15 429P - Brain imaging screening (BIS) in metastatic breast cancer (MBC): Patients’ and physicians’ perspectivesPresenter: Ana Leonor Matos Session: Poster session 15 430P - A novel survival predicting model for breast cancer brain metastasis based on multimodal dataPresenter: Zisheng Wu Session: Poster session 15 431P - Exposure-adjusted incidence rates (EAIRs) of adverse events (AEs) from the TROPION-Breast01 study of datopotamab deruxtecan (Dato-DXd) vs investigator’s choice of chemotherapy (ICC) in patients (pts) with pretreated, inoperable/metastatic HR+/HER2– breast cancer (BC)Presenter: Hope Rugo Session: Poster session 15 432P - Exploratory biomarker analysis of trastuzumab deruxtecan versus treatment of physician’s choice in HER2-low, hormone receptor–positive metastatic breast cancer in DESTINY-Breast04Presenter: Naoto Ueno Session: Poster session 15 433TiP - Phase III, randomized, open-label TroFuse-010 Study of sacituzumab tirumotecan (sac-TMT) alone and with pembrolizumab vs treatment of physician’s choice chemotherapy (TPC) in patients with HR+/HER2- unresectable locally advanced or metastatic breast cancer (mBC)Presenter: Sara Tolaney Session: Poster session 15 This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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