XNCR Xencor

Xencor XmAb819 Phase 1 dose-expansion data in advanced ccRCC

Xencor presented updated results from the dose-expansion cohorts of the Phase 1 study of XmAb819 (ENPP3 x CD3) in patients with relapsed/refractory advanced ccRCC who progressed after ICI and VEGFR-TKI. The presentation includes safety, pharmacokinetics, and preliminary efficacy data from the 100, 200, and 400 µg/kg IV cohorts.

Xencor Presents XmAb819 Phase 1 Data at ESMO 2026, Selects RP3D and Plans FDA Discussion in 1H2027

Xencor presented updated Phase 1 dose-expansion results for XmAb819 in heavily pre-treated advanced ccRCC at ESMO 2026, selecting 400 mcg/kg IV as proposed RP3D based on 45.5% cORR, 55% uORR and 82% 6-month PFS. The company plans to discuss a potential accelerated approval pathway with the FDA in key subgroups in 1H2027 and initiate a global randomized study versus tivozanib by end of 2027.

Xencor XmAb819 Phase 1 ESMO 2026 oral presentation and webcast

Xencor will present Phase 1 results of XmAb819 (ENPP3 x CD3 bispecific) in advanced ccRCC at ESMO Congress 2026 on October 25, including intravenous doses evaluated for recommended Phase 3 dose selection. The company will host a webcast on October 26 to discuss the data and plans to initiate a registration-enabling Phase 3 study in 2027.

tafasitamab · NCT07731789 registry update

status: NOT_YET_RECRUITING → RECRUITING

Xencor: XmAb819 ccRCC data accepted for ESMO 2026 oral presentation

Phase 1 ccRCC expansion-cohort results for XmAb819 will be presented in a proffered-paper oral session at ESMO 2026 (23-27 Oct). The presentation will focus on intravenous dose levels being evaluated as recommended Phase 3 doses.

Incyte: Minjuvi (tafasitamab) approved in Japan for R/R DLBCL

Japan’s MHLW approved Minjuvi (tafasitamab) plus lenalidomide for adults with relapsed or refractory DLBCL. The approval rests on the L-MIND and J-MIND trials showing clinically meaningful ORR and CR rates. This is the second Japanese approval for the product and expands its regulatory footprint in the country.

Incyte frontMIND Phase 3: Tafasitamab + Len + R-CHOP beats R-CHOP in 1L high-risk DLBCL/HGBL

The frontMIND Phase 3 trial met its primary endpoint, showing Tafa-Len-R-CHOP significantly improved PFS (HR 0.75, p=0.0194) versus R-CHOP in previously untreated high-risk DLBCL/HGBL. Positive trends were also seen in EFS and OS, and the data support global regulatory applications for this new first-line regimen.

Incyte: tafasitamab Phase 3 frontMIND data at ASCO 2026

Incyte will present full Phase 3 frontMIND results for tafasitamab plus lenalidomide and R-CHOP in newly diagnosed DLBCL as an oral presentation at ASCO on May 30, 2026. The data are described as positive and will support global regulatory submissions. No PDUFA or approval decision is stated in the release.