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 session434TiP - ALTER-BC-Ib-01: A prospective phase Ib study of anlotinib with trastuzumab deruxtecan (T-DXd) for HER2-low unresectable (u)/metastatic (m) breast cancer (BC)Presenter: Yanchun Meng Session: Poster session 15 436TiP - DYNASTY-Breast02: A phase III trial of BNT323/DB-1303 vs investigator's choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancerPresenter: Joyce O'Shaughnessy Session: Poster session 15 437TiP - An open-label, multicenter, phase II study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC)Presenter: Mridula George Session: Poster session 15 439TiP - AVZO-021-1001: A first-in-human open-label, multicenter phase I/II dose-escalation and expansion study evaluating AVZO-021 in adult patients with advanced solid tumorsPresenter: Afshin Dowlati Session: Poster session 15 517P - Circulating tumor DNA driving anti-EGFR rechallenge therapy in metastatic colorectal cancer: The RASINTRO prospective multicenter studyPresenter: Aziz Zaanan Session: Poster session 15 520P - Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase III FRESCO-2 trialPresenter: Rocio Garcia-Carbonero 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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