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Incyte Announces New Advances in Oncology Portfolio, KRAS Inhibitor Shows Promising Efficacy

Incyte (INCY) announced new results from its advancing oncology portfolio, including updated results for its KRAS G12D inhibitor in pancreatic ductal adenocarcinoma and advanced or metastatic colorectal cancer, and its TGFbetaR2PD-1 bispecific antibody in microsatellite stable CRC. The data were featured in three rapid oral sessions at the European Society of Medical Oncology Congress 2026. INCB161734 in Pancreatic Ductal Adenocarcinoma: ON/OFF KRAS Inhibition Shows Deep and Durable Responses Across Combinations, With Manageable Safety: New Phase 1 data showed encouraging clinical efficacy and a favorable safety profile for INCB161734 1,200 mg once daily in combination with standard-of-care chemotherapy in patients with metastatic PDAC harboring a documented KRAS G12D mutation. Deep and durable treatment responses were observed. Specifically: INCB161734 plus mFOLFIRINOX: Patients treated with INCB161734 in combination with mFOLFIRINOX achieved objective response rates of 89% and 81%, and a disease control rate of 100%. Six-month landmark progression-free survival rate in patients treated with INCB161734 in combination with mFOLFIRINOX was 90%. Median treatment duration for INCB161734 + mFOLFIRINOX was 6 months. No treatment-related adverse events led to treatment discontinuation of INCB161734. The most common TRAEs included diarrhea, nausea, vomiting and decreased neutrophil count . INCB161734 plus GEMNabP: Patients treated with INCB161734 in combination with GEMNabP achieved ORRs of 69% and 58%, and a DCR of 96%. Six-month landmark PFS in patients treated with INCB161734 in combination with GEMNabP was 80%. Median treatment duration for INCB161734 + GEMNabP was 7 months. TRAEs leading to treatment discontinuation of INCB161734 was low. The most common TRAEs included diarrhea, nausea, decreased neutrophil count and anemia. Across treatment groups, INCB161734 in combination with GEMNabP or mFOLFIRINOX was tolerable and the safety and tolerability profile was broadly consistent with established profiles of SoC regimens. GI TRAEs were mostly Grade 1/2 and improved during treatment. The global Phase 3 study evaluating INCB161734 in combination with investigator's choice of both SoC chemotherapies in first-line metastatic PDAC is ongoing with topline data anticipated in 2028. A Phase 3 study in the adjuvant PDAC setting is planned for 2027. Additionally, two new clinical trial collaborations to evaluate novel combinations with INCB161734 in PDAC are planned: A Phase 1b trial will evaluate INCB161734 in combination with navlimetostat, Bristol Myers Squibb's (BMY) MTA-cooperative PRMT5 inhibitor, in patients with advanced or metastatic PDAC. A planned Phase 1b trial will evaluate INCB161734 in combination with SNV1521, Synnovation's PARP1 inhibitor, in patients with advanced or metastatic PDAC. INCB161734 in Colorectal Cancer: Clinical Activity and Manageable Safety as Monotherapy and in Combination in Patients with Advanced/Metastatic CRC: New Phase 1 data demonstrated antitumor activity and a manageable safety profile for INCB161734 1,200 mg QD as monotherapy and in combination with cetuximab in patients with advanced/metastatic KRAS G12D-mutated CRC. Specifically: Heavily pretreated patients who received INCB161734 in combination with cetuximab achieved an ORR of 36% and a DCR of 100%. Median PFS was 7.2 months. As a monotherapy and in combination, INCB161734 had a manageable safety profile. No dose-limiting toxicities were observed in the combination dose escalation, and a maximum tolerated dose was not reached. TRAEs leading to discontinuation or dose modification for INCB171734 were low across monotherapy and combination treatment groups. The Phase 3 study evaluating INCB161734 plus cetuximab for previously treated metastatic CRC is expected to initiate in the first half of 2027. In addition to the previously announced collaboration with Genmab in CRC, Phase 1 studies and cohorts are ongoing or planned to explore INCB161734's potential to address resistance mechanisms, including an ongoing study of INCB161734 plus cetuximab and SoC chemotherapy in front-line metastatic CRC and a tumor-agnostic cohort. INCA33890 in MSS CRC: Notable Clinical Activity Across Treatment Combinations and Key Patient Subgroups, With Manageable Safety: In patients with advanced or MSS CRC, new Phase 1 data demonstrated encouraging preliminary efficacy across cohorts and within subgroups and a manageable safety profile with INCA33890 900 mg intravenously every two weeks in combination with SoC therapies. Of note: In the first-line setting, patients treated with INCA33890 in combination with FOLFOX and bevacizumab achieved a 71% ORR and 100% DCR. The six-month PFS was 81%. Responses were observed across subgroups, with an ORR of 83% in patients with liver metastases and 62% in patients with peritoneal metastases. ORR was 81% in patients with tumors with PD-L1 TAP greater than or equal to1%. The most common treatment-emergent adverse events in the first-line setting were neuropathy, neutropenia and stomatitis. Treatment discontinuation was observed in four patients. INCA33890 in combination with SoC therapies were tolerable with no DLTs observed. The Phase 3 NEXERA-303 study evaluating INCA33890 plus FOLFOX and bevacizumab as a first-line treatment for patients with MSS CRC is ongoing with topline data expected in 2029. A Phase 2 study in MSS CRC in the adjuvant setting post-chemotherapy is also ongoing.

Sichuan Biokin Reports Positive Results for Izalontamab in Lung Cancer Trial

SystImmune and Bristol Myers Squibb announced that SystImmune's parent company Sichuan Biokin reported positive results from a prespecified interim analysis in the randomized, multicenter Phase 3 PANKU-Lung01 study evaluating izalontamab brengitecan, iza-bren, an investigational, first-in-class, dual-targeting EGFRxHER3 bispecific antibody-drug conjugate, ADC, versus platinum-based chemotherapy, PBC, in patients with EGFR-mutated non-squamous non-small cell lung cancer, NSCLC, who were previously treated with an EGFR tyrosine kinase inhibitor. Results will be presented in a late-breaking oral presentation at the European Society for Medical Oncology, ESMO, 2026 Annual Congress and published in The Lancet. Median follow-up for progression-free survival was 14.6 months. Results showed iza-bren significantly improved PFS, the study's primary endpoint, compared to PBC, with a median PFS by Blinded Independent Central Review of 11.1 months for iza-bren vs. 5.7 months for PBC. For the secondary endpoint of overall survival, data were immature, though a favorable trend toward improved OS was observed with iza-bren vs. PBC. The confirmed objective response rate by BICR was 60.2% for iza-bren vs. 34.5% for PBC, and the median duration of response was 10.4 months vs. 5.7 months.

BioNTech and Bristol Myers Squibb Announce Lung Cancer Trial Data

BioNTech (BNTX) and Bristol Myers Squibb Company (BMY) announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator, in combination with docetaxel in patients with metastatic non-small cell lung cancer, NSCLC, whose disease progressed on or after first-line immunotherapy plus chemotherapy. Key highlights: Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy; An early median progression-free survival of 6.9 months was observed; Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel ; Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care