Courtney Flaherty

Jonathan Trent, MD, discusses how proactive AE management, dose individualization, and liquid TKI formulations could improve treatment adherence and outcomes in GIST.

Despite a higher response rate with the combination, the phase 2 MIROVA/AGO-OVAR 2.34 trial did not meet its primary PFS end point over chemotherapy.

The B7-H4–targeted antibody-drug conjugate produced confirmed response rates of 62% in PROC and 67% in endometrial cancer at the doses selected for phase 3 development.

Vincent Picozzi, MD, discusses the PANOVA-3 data supporting the approval of Optune Pax and the future of TTFields in pancreatic cancer.

The FDA has accepted a BLA for ozekibart in unresectable or metastatic conventional chondrosarcoma, setting a PDUFA goal date of April 14, 2027.

The FDA has accepted for review an sBLA for adjuvant atezolizumab plus chemotherapy in stage III dMMR/MSI-H colon cancer.

Marwan G. Fakih, MD, discusses how updated OS data from POD1UM-303 cement frontline retifanlimab plus chemotherapy as the standard of care in advanced SCAC.

Oncology experts provide commentary on the meeting's biggest and most impactful presentations across the GI cancer continuum.

Need a refresh on the current regulatory landscape for GI oncology? We've got you covered. Here's everything that moved the needle across GI malignancies this month.

Phase 1/2 data show that the PRMT5 inhibitor vopimetostat plus daraxonrasib yielded a 92% ORR in MTAP-deleted, RAS-mutant metastatic pancreatic cancer.

In the phase 3 RECITE trial, romiplostim significantly reduced chemotherapy dose modifications due to thrombocytopenia vs placebo in gastrointestinal cancers.

The novel MEK1/2 inhibitor produced an ORR of 36% and a median OS of 17.3 months in all-comers, supporting its advancement in the phase 3 MAPKeeper 301 trial.

STRIDE plus lenvatinib and TACE significantly improved PFS vs TACE alone in patients with unresectable embolization-eligible HCC.

In the phase 3 RASolute 302 trial, daraxonrasib nearly doubled OS vs chemotherapy in previously treated metastatic PDAC, cutting the risk of death by 60%.

Extended follow-up data from NRG-GY018 show a sustained OS benefit with pembrolizumab plus chemotherapy regardless of MMR status or post-study ICI therapy.

Replimune plans to resubmit a BLA for RP1 plus nivolumab after the FDA agreed to prioritize review due to the significant unmet need in advanced melanoma.

The FDA has accepted for review an NDA for bezuclastinib plus sunitinib in imatinib-pretreated GISTs, with a PDUFA date of November 30, 2026.

Neil D. Gross, MD, FACS, discusses how anti–PD-1 therapy is changing treatment approaches in advanced CSCC.

The European Medicines Agency’s CHMP has issued a positive opinion for encorafenib plus cetuximab and mFOLFOX6 in first-line BRAF V600E–mutant mCRC.

Marwan G. Fakih, MD, outlines situations when ctDNA and tissue NGS agree, when they diverge, and scenarios that should prompt repeat liquid biopsy testing.

Gerald Soff, MD, discusses how romiplostim could improve long-term outcomes in patients with GI cancer and thrombocytopenia by preserving relative dose intensity.

A supplemental BLA for nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with papillary-only disease is under review by the FDA.

The FDA has granted fast track designation to suplexa in MSI-H CRC.

Polls highlighted key abstracts of interest from the upcoming ASCO Annual Meeting.

Ahead of the 2026 ASCO Annual Meeting, experts in GI malignancies share the most anticipated research being presented during the meeting.

Aparna R. Parikh, MD, emphasizes the feasibility of immunotherapy trials in SCAC and the need for better treatment options in the second line and beyond.

Phase 1/2 data showed an ORR of 35% with daraxonrasib in second-line RAS G12-mutated pancreatic ductal adenocarcinoma.

R. Lor Randall, MD, FACS, discusses how the introduction of systemic therapies such as pimicotinib in TGCT enables a tumor biology–informed approach to care.

Pelareorep plus bevacizumab and FOLFIRI showed a 33% response rate and 19.5-month median response duration in RAS-mutant MSS CRC.

A one-stop-shop for regulatory updates across GI malignancies from the past month.