Feb. 2026 for "comparison":
The FDA has granted fast track designation to the intravenously delivered oncolytic virus immunotherapy pelareorep (Reolysin) in combination with bevacizumab (Avastin) and FOLFIRI (leucovorin, 5-fluorouracil [5-FU], irinotecan) for the treatment of patients with KRAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) in the second line.1
The designation was supported by findings from the phase 1 REO 022 trial (NCT01274624),
Reported Serious Adverse Events (Grade 3 or Higher)In clinical trials, particularly in combinations with regimens like mFOLFIRINOX or gemcitabine, the following serious or severe side effects have been reported:
Hematological Toxicities:
Grade 3-4 Neutropenia (low white blood cell count), Anemia, and Thrombocytopenia (low platelet count).
Gastrointestinal Distress:
Severe nausea, vomiting, abdominal pain, and diarrhea.
General Health:
Fatigue (Grade 3), general health deterioration, and dehydration.
Infections:
COVID-19 and other infections.
Other Serious Events:
Acute kidney injury, pulmonary embolism, hypophysitis (inflammation of the pituitary gland), and ileus.
Infusion Reaction:
Significant hypotension (low blood pressure) was reported in rare, higher-dose cases.
Other than it was a Phase 1 FDA designation, & much earlier dosing ---
Dr. J just said on webcast:
*Leronlimab @ mCRC has no Grade 3/4 safety issues
*Leronlimab appears to be Kras agnostic
& Dr. Kasi webcast comment related to 1 week results, is worthy of repeating:
Don't overlook the 1 week too:
At City of Hope, we are one of the centers of excellence that they can put something called a liver pump or medically pronounced as the HAI or the hepatic arterial infusion pump for liver-dominant disease.
It allows 30x the amount of chemo to be given in the liver. So this person had that installed as well and completed all that therapy.
But then after a few months of disease control lo and behold, there was reemergence of liver metastases as well as lung metastases and also was RAS mutant, which by all means when you look at a patient with metastatic colorectal cancer, presence of mutations, presence of liver metastases, number of lines of therapy, this is the kind of patient that an average trial will probably refuse.
So the fact that when we started this patient on treatment as early as a week into treatment and also to the last bullet point that was made on the last slide, improvement in pain as early as 1 week was something that was very reassuring to me for not just this, but for many other patients.
The FDA has granted fast track designation to the intravenously delivered oncolytic virus immunotherapy pelareorep (Reolysin) in combination with bevacizumab (Avastin) and FOLFIRI (leucovorin, 5-fluorouracil [5-FU], irinotecan) for the treatment of patients with KRAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) in the second line.1
The designation was supported by findings from the phase 1 REO 022 trial (NCT01274624),
Reported Serious Adverse Events (Grade 3 or Higher)In clinical trials, particularly in combinations with regimens like mFOLFIRINOX or gemcitabine, the following serious or severe side effects have been reported:
Hematological Toxicities:
Grade 3-4 Neutropenia (low white blood cell count), Anemia, and Thrombocytopenia (low platelet count).
Gastrointestinal Distress:
Severe nausea, vomiting, abdominal pain, and diarrhea.
General Health:
Fatigue (Grade 3), general health deterioration, and dehydration.
Infections:
COVID-19 and other infections.
Other Serious Events:
Acute kidney injury, pulmonary embolism, hypophysitis (inflammation of the pituitary gland), and ileus.
Infusion Reaction:
Significant hypotension (low blood pressure) was reported in rare, higher-dose cases.
Other than it was a Phase 1 FDA designation, & much earlier dosing ---
Dr. J just said on webcast:
*Leronlimab @ mCRC has no Grade 3/4 safety issues
*Leronlimab appears to be Kras agnostic
& Dr. Kasi webcast comment related to 1 week results, is worthy of repeating:
Don't overlook the 1 week too:
At City of Hope, we are one of the centers of excellence that they can put something called a liver pump or medically pronounced as the HAI or the hepatic arterial infusion pump for liver-dominant disease.
It allows 30x the amount of chemo to be given in the liver. So this person had that installed as well and completed all that therapy.
But then after a few months of disease control lo and behold, there was reemergence of liver metastases as well as lung metastases and also was RAS mutant, which by all means when you look at a patient with metastatic colorectal cancer, presence of mutations, presence of liver metastases, number of lines of therapy, this is the kind of patient that an average trial will probably refuse.
So the fact that when we started this patient on treatment as early as a week into treatment and also to the last bullet point that was made on the last slide, improvement in pain as early as 1 week was something that was very reassuring to me for not just this, but for many other patients.
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