Clinical trialsCompany release

Xencor cites 45.5% response rate for XmAb819 in kidney cancer ahead of FDA talks

🇺🇸 Xencor Inc (XNCR) · Wed 04 Nov 2026

The company plans to meet the FDA in the first half of 2027 on a possible accelerated approval route for its ENPP3 x CD3 bispecific antibody.

Xencor reported third-quarter 2026 results on 4 November and used the update to outline progress across its pipeline, led by early data for XmAb819 in kidney cancer.

Data presented at ESMO showed a confirmed response rate of 45.5% for XmAb819, a bispecific antibody targeting ENPP3 and CD3, at an intravenous dose of 400 mcg/kg. The patients had advanced clear cell renal cell carcinoma. The cohort was small, at 11 patients.

Xencor intends to meet the US Food and Drug Administration in the first half of 2027 to discuss a potential accelerated approval path. Subject to the agency's feedback, it plans to start a Phase 3 trial against tivozanib by the end of 2027.

Elsewhere in the pipeline, data for plamotamab in rheumatoid arthritis will be presented at the American College of Rheumatology meeting on 9 November. The primary analysis of the Phase 2b trial of XmAb942 in ulcerative colitis is expected in the second half of 2027.

For context, accelerated approval is a US pathway that allows a medicine for a serious condition to be authorised on an intermediate endpoint reasonably likely to predict clinical benefit, usually with confirmatory trials required.

What it means for your team

  • The planned first-half 2027 FDA meeting is the next regulatory checkpoint: its outcome will show whether a response-rate-based accelerated route is open for XmAb819.
  • The efficacy signal rests on 11 patients, so regulators are likely to look closely at how the Phase 3 design against tivozanib supports any early approval.
  • Teams tracking bispecific T-cell engagers should note Xencor's wider autoimmune activity, with plamotamab data at ACR on 9 November and the XmAb942 Phase 2b readout due in the second half of 2027.

Company's press release (SEC filing): Xencor Inc ↗

Article written by VigiEye from the official source (Xencor Inc). Claims are the company's own. AI-assisted; check the source before acting.

More Clinical trials All →