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 session533P - First-line treatment in older patients with metastatic colorectal cancer: A large real-world studyPresenter: debora basile Session: Poster session 15 534P - Second-line treatment in older patients with metastatic colorectal cancer: The ELECTRA studyPresenter: Alessia Cordua Session: Poster session 15 535P - Safety and efficacy of first-line immune checkpoint inhibitors in elderly colorectal cancer patients: An Italian real-world multicenter experiencePresenter: Alessandra Boccaccino Session: Poster session 15 536P - A randomized phase II/III trial comparing hepatectomy followed by mFOLFOX6 with hepatectomy alone for liver metastasis from colorectal cancer: Long-term results of JCOG0603Presenter: Yukihide Kanemitsu Session: Poster session 15 537P - Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE)Presenter: Yajiie Chen Session: Poster session 15 538P - Combined hepatectomy with complete cytoreduction (CCS) and hyperthermic intraperitoneal chemotherapy (HIPEC) vs. HIPEC alone for metastatic colorectal cancer: A systematic review and meta-analysisPresenter: Gabriele Lech Session: Poster session 15 540P - Early treatment discontinuation (ETD) in dMMR/MSI-H metastastic colorectal cancer (mCRC) treated with immune checkpoint inhibitors (ICIs)Presenter: Julien Taieb Session: Poster session 15 541P - Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Subgroup efficacy and expanded safety analyses from CheckMate 8HWPresenter: Thierry André 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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