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Dr. Filippo Pietrantonio discusses OrigAMI-1 trial data which assessed Rybrevant in mutated, wild-type, non-HER2-amplified metastatic colorectal cancer.
At the 2025 ASCO Gastrointestinal Cancers Symposium, investigators, such as Dr. Filippo Pietrantonio, shared data on the OrigAMI-1 trial which assessed Rybrevant (amivantamab) as a monotherapy and in combination with chemotherapy in patients with mutated, wild-type, non-HER2-amplified metastatic colorectal cancer (mCRC). In an interview with CURE, Pietrantonio broke down the data that were shared at the meeting.
The responses that patients had to treatment were durable, with median duration of response of 7.4 months with the monotherapy and 5.8 months for combination therapy. The safety profile was also consistent with previous findings, including things like rash and hypoalbuminemia as the most common grade 3 (severe) or higher side effects. As of August 26, 2024, 23 patients received the monotherapy, with an objective response rate (ORR) of 22% and a disease control rate (DCR) of 78%. Among seven patients receiving Rybrevant plus chemotherapy, the ORR was 43% and DCR was 86%.
Duration of response: the amount of time a patient's tumor responds to treatment without growing or spreading.
intravenous (IV): a method of administering medication directly into the bloodstream through a vein.
Objective response rate (ORR): the percentage of patients in a study who have a partial or complete response to a treatment.
Read more about next steps with the trial and insights from Pietrantonio, who serves as the Head of the Gastrointestinal Oncology Unit at Fondazione IRCCS Istituto Nazionale dei Tumori, in Milan, Italy, below!
Transcript:
Given the promising anti-tumor activity of Rybrevant in this patient population, two phase three trials are planned and are ongoing in patients with mCRC [whose disease has] KRAS and BRAF wild-type type status. OrigAMI-2 [will serve] as phase three study comparing doublet chemotherapy plus Rybrevant versus the same chemotherapy backbone plus cetaximab in patients with left-sided tumors. [Additionally], OrigAMI-3 is another phase 3 trial investigating Rybrevant irrespective of primary tumor location, so including patients with right-sided tumors. This phase three trial compares second-line treatment with [chemotherapy] plus Rybrevant versus the same chemotherapy regimen plus cetaximab or bevacizumab.
The [advantage] point of these trials is that a more convenient subcutaneous formulation of Rybrevant will be used. This is much more tolerable the intravenous formulation used in the previous studies, including OrigAMI-1, because of the lower incidence of infusion reactions. Improving the treatment compliance and tolerability is important for patients and for the overall safety profile of this novel combination, so we are [looking forward to] coupling a good safety profile with potentially higher efficacy.
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