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Association details:
| Biomarker: | KRAS mutation |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Avastin (bevacizumab) (VEGF-A inhibitor) + onvansertib (PCM-075) (PLK1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
397P - Early decreases in KRAS mutant allele frequency (MAF) predicts clinical benefit to the PLK1 inhibitor onvansertib in combination with FOLFIRI/bev in 2L treatment of metastatic colorectal carcinoma (mCRC)
Published date:
09/05/2022
Excerpt:
17 (35%) pts had a response (1CR, 16PR), including 14 (29%) confirmed responses (1 CR, 13 PR). Median PFS was 9.4 mos (CI: 7.6- NR)...Onv+FOLFIRI/bev shows promising efficacy compared to historical control of FOLFIRI/bev for 2L mKRAS mCRC.
Secondary therapy:
FOLFIRI
Trial ID:
Source:
Title:
366P - The PLK1 inhibitor onvansertib overcomes irinotecan resistance in RAS-mutated (mRAS) metastatic colorectal cancer (mCRC) in vivo and in patients (pts)
Published date:
09/05/2022
Excerpt:
In the EAP, 43 mKRAS mCRC pts with prior irinotecan treatment received Onv+FOLFIRI/bev. As of 10-Mar-2022, median PFS was 4 mos (range 0.4-17.4), with 14 (33%) of pts benefiting for >6 months. Five pts remained on treatment at data cutoff for 9.3 to 17.4 mo. Of the 32 pts evaluable for KRAS MAF changes, pts with a decrease in KRAS MAF of ≥90% (n=11) had a significantly longer PFS of 11.1 mo (CI 5.5-NR)...Preclinical and clinical data support that Onv can overcome irinotecan-resistance in mRAS CRC.
Secondary therapy:
FOLFIRI
Source:
Title:
A phase 1b/2 trial of the PLK1 inhibitor onvansertib in combination with FOLFIRI-bev in 2L treatment of KRAS-mutated (mKRAS) metastatic colorectal carcinoma (mCRC).
Published date:
01/18/2022
Excerpt:
The combination of onvansertib with FOLFIRI-bev was well tolerated: observed TEAEs have been generally low-grade and manageable. The combination has demonstrated a promising ORR in 2L treatment of mCRC pts harboring various KRAS mutations, and efficacy was correlated with early changes in plasma mKRAS.
Secondary therapy:
FOLFIRI
DOI:
10.1200/JCO.2022.40.4_suppl.100
Trial ID:
Title:
Cardiff Oncology Announces New Data from Phase 1b/2 Trial in KRAS-mutated Metastatic Colorectal Cancer Showing Robust Objective Response Rate and Progression Free Survival
Published date:
09/08/2021
Excerpt:
Cardiff Oncology...today announced new data from its...onvansertib in combination with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).....8 of 19 (42%) patients...who were evaluable for disease response as of the data cut-off achieved a partial response (PR). ..12 of 32 (38%) patients evaluable for response as of data cutoff date across all dose levels achieved a PR...The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated.
Secondary therapy:
FOLFIRI
Trial ID:
Title:
Cardiff Oncology Announces Onvansertib Phase 1b/2 Data that Continues to Demonstrate Robust Response to Treatment and Progression-Free Survival in KRAS-Mutated mCRC
Published date:
04/12/2021
Excerpt:
Patients enrolled in the ongoing Phase 1b/2 trial receive onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab)....Clinical responses were observed across different KRAS mutations, including the 3 most common in colorectal cancer (G12D, G12V, G13D)
Secondary therapy:
FOLFIRI
Trial ID:
