5 Key Takeaways

• 1

  Merck's sacituzumab tirumotecan met phase 3 endpoints in advanced endometrial cancer, showing improved overall and progression-free survival.

• 2

  Microbiotica's MB097, a microbiome therapy, demonstrated positive phase 1b results in advanced melanoma when combined with pembrolizumab.

• 3

  Akeso's ligufalimab, an anti-CD47 monoclonal antibody, showed a survival signal in phase 2 trials for treatment-naïve acute myeloid leukemia.

• 4

  Regeneron's phase 3 trial of fianlimab and cemiplimab in melanoma did not achieve statistical significance for progression-free survival.

• 5

  The FDA finalized guidance on postapproval pregnancy safety studies to enhance safety data collection for drugs and biologics used during pregnancy.