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 session393P - A phase II study to evaluate the efficacy and safety of TSL-1502 capsules in breast cancer patients with germline BRCA mutationsPresenter: Bo Lan Session: Poster session 15 394P - Quantitative standardized high sensitivity (HS)-HER2 testing predicts outcomes with trastuzumab deruxtecan (T-DXd) for metastatic breast cancer (MBC)Presenter: Paolo Tarantino Session: Poster session 15 395P - Receptor status heterogeneity during metastatic breast cancer treatmentPresenter: Sandra Geurts Session: Poster session 15 396P - Evaluation of MUC1-C/CD3 biparatopic-bispecific (BPBS) T cell engager as an immunotherapeutic agent for the treatment of MUC1-expressing metastatic breast cancer (mBC)Presenter: Ravi Jasuja Session: Poster session 15 397P - Survival of de novo metastatic breast cancer according to biomarker status in Denmark and Norway: A register-based cohort studyPresenter: Johan Liseth Hansen Session: Poster session 15 398P - Age and ethnic-driven molecular and clinical disparity of East Asian breast cancersPresenter: Ji Yoon Lee Session: Poster session 15 399P - Treatment patterns and outcomes in HER2-low, HR+ metastatic breast cancer patients previously treated with endocrine therapy in the United StatesPresenter: Shanu Modi Session: Poster session 15 400P - LncRNA-LINC00294 functions as a ceRNA in regulating JUP through competitively binding to miR-485-5p in breast cancerPresenter: Ting Yang Session: Poster session 15 Resources: Abstract 401P - Evaluation of HER2 scoring in breast carcinoma-stained whole slide imagesPresenter: Céline Bossard Session: Poster session 15 402P - Inflammatory biomarkers for predicting the efficacy of immunotherapy in advanced breast cancerPresenter: Kuikui Jiang 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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