Bassam Sonbol, Oncologist at Mayo Clinic Arizona, shared a post on X:
“Phase 3 data from FIGHT-302 just published in Journal of Clinical Oncology, led by Tanios Bekaii-Saab.
In FGFR2-rearranged cholangiocarcinoma, pemigatinib vs Gem/Cis showed:
- Improved PFS (8.3 vs 6.8 mo)
- Higher ORR (47% vs 15%)
- More durable responses (14.2 vs 6.3 mo)
- Similar OS (24.4 vs 25.0 mo)
The trial closed early after the standard of care shifted with TOPAZ-1 and KN-966.
167 patients were randomized after screening thousands of patients. This reflects how challenging these trials are . FGFR2 rearrangements occur in only ~6% of biliary tract cancers. Crossover to pemigatinib was permitted in the control arm. Even after statistical adjustment for crossover, OS remained similar.
Arguments for considering pemigatinib up front:
- The response rate and durability are meaningfully better.
- In practice we lose patients between lines due to toxicity or declining performance status. For those with bulky or symptomatic disease who need a rapid, deep response, starting with the FGFR inhibitor may be the better option.
Arguments for chemo + IO first:
Even accounting for crossover, there was no OS advantage to starting with pemigatinib. This supports that current standard chemo + immunotherapy followed by pemigatinib on progression remains a reasonable strategy for many patients. Those who received chemo upfront on study and progressed had worse outcomes (small sample size n=14). The argument with IO is always re- durable responses. mDOR with pemigatinib here is 14 mo. We will have to see long-term how that will compare to IO-based strategy. (note: IO barely added any responses to Gem+cis)
If gets approved, pt with advanced FGFR2-altered BTC first-line, which would you choose?
- Gem CIs + durva/pembro
- Pemigatinib
- Other
Congratulations to all the authors Arndt Vogel, Lorenza Rimassa and especially my friend and mentor Tanios Bekaii-Saab.
Executing this took tremendous efforts.”
Title: Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase 3 FIGHT-302 Trial
Authors: Tanios S. Bekaii-Saab, Davide Melisi, Hanneke Wilmink, Carlo Garufi, Nguyen Tran, Giampaolo Tortora, Filippo De Braud, Jan-Erik Frodin, Sara Lonardi, Emily Lin, Hani Babiker, Bruce Lin, Lorenzo Fornaro, Andrés Muñoz Martín, John Bridgewater, Jennifer J. Knox, Judith De Vos-Geelen, Martin Scott-Brown, Luisa Veronese, Sonia Ioannidis, Aidan Gilmartin, John E. Janik, Yufei Guo, Junji Furuse, Tatsuya Ioka, Lorenza Rimassa, Arndt Vogel.
Other articles featuring Bassam Sonbol on OncoDaily.
