Taiho Oncology’s LONSURF received the FDA’s nod for CRC in combination with Bevacizumab

CAR-T Digest - August 2020

02 Aug 2023: LONSURF (trifluridine/tipiracil) / Bevacizumab / mCRC / Taiho Oncology: Approved in the US

Based on the results from the Phase 3 SUNLIGHT study, LONSURF received approval for mCRC (3L) in the US
Efficacy: N = 246; (LONSURF + Bevacizumab vs LONSURF)
- mOS: 10.8 months vs 7.5 months
  - This improvement in OS represented a 39% reduction in the risk of death in patients with mCRC
- mPFS: 5.6 months vs 2.4 months indicating a 56% relative risk reduction of disease progression
- Median time to worsening of the ECOG performance status score from 0 or 1 to 2 or more: 9.3 months vs 6.3 months
Safety:
- The most frequent severe TEAEs: Neutropenia (43.1% vs 32.1%) and anemia (6.1% vs 11.0%)
This data was also published in the New England Journal of Medicine
In Aug’23, the EU approved LONSURF in combination with Bevacizumab for the same patient segment
- It is also approved in Japan for unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy
“The FDA approval of LONSURF in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.” said Timothy Whitten, President and Chief Executive Officer, Taiho Oncology