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 session523P - A phase II study of intrapatient dose escalation of biweekly trifluridine/tipiracil plus bevacizumab for colorectal cancer (E-BiTS study)Presenter: Munehiro Wakabayashi Session: Poster session 15 524P - A phase II study of alpelisib, a PIK3CA inhibitor, and capecitabine in patients with metastatic colorectal cancer who failed two prior standard chemotherapiesPresenter: Ahreum Lim Session: Poster session 15 525P - Final analysis of the JACCRO CC-16: Ramucirumab plus FOLFIRI for RAS wild-type mCRC refractory to anti-EGFR antibodyPresenter: Keiji Sugiyama Session: Poster session 15 526P - Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by agePresenter: Maria Elena Elez Fernandez Session: Poster session 15 527P - Effect of trifluridine/tipiracil (FTD/TPI) in combination with bevacizumab (bev) in patients treated in SUNLIGHT by clinical prognostic factors at baselinePresenter: Josep Tabernero Session: Poster session 15 529P - Evaluating metastatic disease sites as a prognostic marker in patients receiving sequential treatment with regorafenib and trifluridine/tipiracil for refractory colorectal cancer: Survival outcomes from the multicenter retrospective “ReTrITA” studyPresenter: Carlo Signorelli Session: Poster session 15 530P - Real-world effectiveness and predictive biomarker analysis of TAS-102+bevacizumab vs. regorafenib vs. TAS-102 in metastatic colorectal cancer: A multicenter cohort studyPresenter: Andreas Seeber Session: Poster session 15 531P - Prognostic value of liver metastases, KRAS mutations and race in colorectal cancer patients: A pooled analysis of third-line placebo-controlled trials from the ARCAD databasePresenter: Thierry André Session: Poster session 15 532P - G-CSF secondary prophylaxis in patients (pts) with metastatic colorectal cancer (mCRC) treated with trifluridine/tipiracil (FTD/TPI): The GERCOR LONGBOARD studyPresenter: Jean-Baptiste Bachet 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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