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 session375P - Results from the Danish Breast Cancer Group's (DBCG) NAME-trial: A direct comparison of oral navelbine given either classic or metronomic in metastatic breast cancerPresenter: Anne Sofie Brems-Eskildsen Session: Poster session 15 376P - Evaluating adherence to oral anticancer medications in metastatic and non-metastatic breast cancer patientsPresenter: Rana El-Shewy Session: Poster session 15 377P - Phase II study of trifluridine/tipiracil in pre-treated patients with ER-positive, HER2-negative metastatic breast cancer: A Dutch BOOG (2019-01 TIBET) studyPresenter: Niels Guchelaar Session: Poster session 15 378P - Updated data on real-world efficacy and safety of inetetamab-based therapy in HER2-positive metastatic breast cancer patients with prior exposure to trastuzumabPresenter: Duan Yang Session: Poster session 15 379P - Safety and efficacy of trastuzumab deruxtecan and concomitant radiation therapy in patients with metastatic breast cancer: A multicentre international retrospective cohort studyPresenter: Luca Visani Session: Poster session 15 381P - Treatment rechallenge after grade 1 trastuzumab-deruxtecan related interstitial lung disease: A real-world experiencePresenter: Kelsey Natsuhara Session: Poster session 15 382P - Pyrotinib combined with metronomic oral etoposide (VP-16) in heavily pretreated HER2-positive metastatic breast cancer: A single-arm, phase II studyPresenter: Jiaxuan Liu 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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