Nicholas Hornstein, Assistant Professor at Northwell Health, shared a post on LinkedIn:
“How often does a company stop an actively enrolling global phase III trial and open an entirely new registration study?
Well, it happened last week.
Agenus is moving from BATTMAN to ROBBIN.
BATTMAN was testing BOT/BAL against best supportive care in refractory MSS metastatic colorectal cancer. An important question, but a best supportive care control was never likely to gain traction in the United States.
ROBBIN moves BOT/BAL where it may have its best chance to work: previously untreated, high-risk stage II/III MSS colon cancer, before surgery and while the primary tumor remains intact.
The rationale borrows from FOxTROT and builds on early neoadjuvant immunotherapy work from MSK and others like Pashtoon Kasi.
The early BOT/BAL data are compelling:
- Pathologic response in approximately 60–70%
- Major pathologic response in ~35–40%
- pCR in ~30%
Those are extraordinary numbers for MSS colon cancer and outperform the chemotherapy experience from FOxTROT.
ROBBIN will randomize 850 patients to short-course neoadjuvant BOT/BAL followed by standard care versus standard care alone, with event-free survival as the primary endpoint.
Will the pathologic responses translate into fewer recurrences?
I think there is a real chance they will.
The tradeoff will be toxicity. Grade 3 colitis/diarrhea occurred in 13% in one of the early cohorts, although there were no grade 4 events and almost no impact on surgical timing.
So yes, you can still smell the colitis.
But it may be worth it.”
You can also read ‘ASCOLT Translational Study and Meta-analysis: Adjuvant Aspirin in Molecularly Selected Colorectal Cancer‘
