Abstract 644P
Background
Rivoceranib (Rivo) is a novel oral TKI that potently and selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR2). Selective inhibition of VEGFR2 has been shown to enhance the efficacy of chemotherapy. Herein, we present safety and efficacy results of the phase 1b portion of this study evaluating Rivo in patients (pts) with previously treated metastatic colorectal cancer.
Methods
In phase 1b of the study, a 3+3+3 dose-escalation was conducted to identify the recommended phase 2 dose (RP2D) of Rivo to be used in combination trifluridine/tipiracil. The phase 2 portion will evaluate the RP2D of Rivo PO QD (Days 1-28) in combination with trifluridine/tipiracil 35 mg/m2 PO BID (Days 1-5, 8-12 Q28 days).
Results
As of September 2022, 29 pts received treatment with Rivo. The median age was 54 yrs (range, 30-80), most pts were male (55.2%) and White (86.2%), ECOG PS was 0 (55.2%) or 1 (44.8%), and most pts received 3 (24.1%) or 4 (24.1%) prior lines of systemic therapy. Efficacy results at each dose level are summarized in the table. Dose limiting toxicities included myelosuppression, nausea, diarrhea, fatigue, asthenia, anorexia, proteinuria and arrythmia. No treatment-related deaths occurred. The patient who received the longest duration of treatment (>26 cycles) continues to receive treatment with rivoceranib.
Table: 644P
Efficacy results (intent-to-treat population)
| 300 mg (n=7) | 400 mg (n=7) | 500 mg (n=8) | 600 mg (n=7) | |
| ORR, n (%) | 0 | 0 | 1 (12.5) | 0 |
| BOR per RECIST v1.1 | ||||
| PR, n (%) | 0 | 0 | 1 (12.5) | 0 |
| SD, n (%) | 4 (57.1) | 5 (71.4) | 4 (50.0) | 1 (14.3) |
| PD, n (%) | 2 (28.6) | 1 (14.3) | 3 (37.5) | 4 (57.1) |
| NE, n (%) | 1 (14.3) | 1 (14.3) | 0 | 2 (28.6) |
| mPFS, mo (95% CI) | 3.9 (0.9,8.3) | 4.2 (1.8,NE) | 3.6 (1.8,14.6) | 2.1 (1.2, NE) |
| mOS, mo (95% CI) | 13.4 (1.9, 26.9) | 6.7 (3.1, NE) | 11.3 (3.3, NE) | 7.6 (5.2, NE) |
| OS at 12 mo (95% CI) | 57.1 (17.2,83.7) | 42.9 (9.8,73.4) | 50.0 (15.2,77.5) | 33.3 (4.6,67.6) |
Conclusions
Rivo 400 mg PO QD is the RP2D to be used in combination with trifluridine/tipiracil 35 mg/m2 PO BID.
Clinical trial identification
NCT04073615.
Editorial acknowledgement
The Phillips Group Oncology Communications, Inc.
Legal entity responsible for the study
Elevar Therapeutics.
Funding
Elevar Therapeutics.
Disclosure
C.H. Park, X. Meng, S.H. Jang: Financial Interests, Personal, Full or part-time Employment: Elevar Therapeutics; Financial Interests, Personal, Stocks or ownership: Elevar Therapeutics. All other authors have declared no conflicts of interest.
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