cinrebafusp alfa (PRS-343)

Cinrebafusp alfa demonstrates promising activity in patients with HER2-positive malignancies who have progressed on prior HER2-targeting regimens. Its acceptable safety profile suggests it could be a treatment option for patients not responding to existing HER2-directed therapies.

P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Trial completion date: Oct 2021 --> Dec 2023 | Trial primary completion date: Oct 2021 --> Dec 2023

P1, N=41, Completed, Pieris Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1

The combination of cinrebafusp alfa with ramucirumab and paclitaxel was safe and tolerated in the 5 patients treated. Preliminary activity of cinrebafusp alfa in combination with ramucirumab and paclitaxel demonstrated a high response rate indicating that the combination can elicit clinical responses in patients who have progressed on trastuzumab deruxtecan or checkpoint inhibitor regimens.

No abstract available

Background: For patients (pts) with HER2-overexpressing metastatic gastric cancer, trastuzumab + chemotherapy +/- pembrolizumab is a standard first-line option but only provides an incremental overall survival (OS) benefit vs chemotherapy. Recruitment is ongoing. Approximately 10 sites in 3 countries in US, Asia and Europe are expected to participate.

P1, N=85, Completed, Pieris Pharmaceuticals, Inc. | Recruiting --> Completed | Trial primary completion date: May 2021 --> Oct 2021

The authors did not submit an updated abstract. The original abstract should be considered final.

P1b, N=45, Active, not recruiting, Pieris Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting

P1, N=110, Recruiting, Pieris Pharmaceuticals, Inc. | Suspended --> Recruiting | Trial completion date: May 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> May 2021

P1b, N=45, Recruiting, Pieris Pharmaceuticals, Inc. | Suspended --> Recruiting | Trial completion date: Feb 2021 --> Jul 2021 | Trial primary completion date: Dec 2020 --> May 2021

P1, N=110, Suspended, Pieris Pharmaceuticals, Inc. | N=78 --> 110 | Trial completion date: Sep 2020 --> May 2021 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Jan 2021

P1b, N=45, Suspended, Pieris Pharmaceuticals, Inc. | N=70 --> 45 | Trial completion date: Aug 2020 --> Feb 2021 | Recruiting --> Suspended | Trial primary completion date: Apr 2020 --> Dec 2020

We will also present results of a PRS-343/atezolizumab combination trial in HER2+ solid tumors...Based on these data, a phase II trial in gastric/GEJ cancer has been planned in combination with ramucirumab and paclitaxel...Funding: Pieris Pharmaceuticals. Clinical trial identification: NCT03330561.