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Avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as a rechallenge strategy: The phase II CAVE (cetuximab-avelumab) mCRC study
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EGFR + PD1/PDL-1 inhibtor for RAS/BRAF WT mCRC pts: Looks promising but more data required
Abstract No : Abstract #2993
Indication : Colorectal Cancer
Intervention : Cetuximab + Avelumab
Company : Merck & Co.
Technology : Immune Checkpoint Inhibitor (ICI)
Results:
From August 10, 2018 to February 21, 2020, 77 pts have been enrolled and started treatment with avelumab 10 mg/kg q14 and cetuximab at 400 mg/m2 and subsequently 250 mg/m2 weekly until progression of disease (PD) or unacceptable toxicity. Kaplan-Meier curves estimated for the whole intention-to-treat (ITT) population (77 pts): mOS was 13.1 mo (95% Confidence Interval CI, 7.4-18.8 mo; 32 events); mPFS, 3.6 mo (95% CI, 3.3-3.9 mo; 62 events). Among 65 pts evaluable for response, 1 pt (1.5%) experienced CR, 3 pts (4.6%) PR, 32 pts stable disease (SD) (49.2%); 29 pts PD (44.6%). Pts with PFS≥ 6 mo were 12/65 (18.5%). Grade-3 adverse events were reported in 16/77 pts (22%), the most common being skin rash 10/77 (13%) and diarrhoea 3/77 (4%).
Conclusion:
At this preliminary analysis, avelumab plus cetuximab as a rechallenge strategy is effective and well tolerated in chemorefractory RAS/BRAF WT mCRC pts.
Executive Summary
The study demonstrated that this combination is effective, well tolerated and feasible in pre-treated chemo-refractory RAS WT mCRC patients. This chemotherapy free regimen compares favourably with current standard 3L therapies in respect of safety and efficacy. The study achieved the primary end point and is clinically relevant with median OS of 13.1 months, together with disease control rate in 65% of patients, and with median PFS of 3.6 months [(PFS: 70/77 (91%) events, OS: 37/77 (48%)]. Randomized Phase III study warranted in which cetuximab + avelumab would be compared to third line standard of care therapy.