Compass Therapeutics (NASDAQ:CMPX) Chief Executive Officer Thomas Schuetz said the company remains confident in the clinical and regulatory outlook for tovecimig following results from the COMPANION-002 study, emphasizing that crossover in the control arm affected the intent-to-treat overall survival analysis.
Speaking in a Q&A hosted by Stifel senior biotech analyst Stephen Willey, Schuetz said the company does not view the overall survival data as showing a numerical detriment for tovecimig. He said the nominal hazard ratio was influenced by patients in the control arm who crossed over and received the active drug.
Schuetz contrasted the study’s results with historical outcomes in second-line biliary tract cancer, noting that three-drug chemotherapy regimens in prior studies have shown median overall survival of about six months. In COMPANION-002, he said patients who received tovecimig plus paclitaxel had median overall survival of 9.9 months, while patients who received paclitaxel alone had median overall survival of 6.1 months.
He also pointed to the trial’s primary endpoint, saying COMPANION-002 had already met its primary endpoint of overall response rate and also achieved a statistically significant improvement in progression-free survival.
FDA Meeting Expected This Summer
Schuetz said Compass is preparing for an interaction with the U.S. Food and Drug Administration this summer and is continuing to prepare for a Biologics License Application. He said the company’s regulatory consultants have advised seeking full approval based on the available data, though Accelerated Approval could also be discussed.
“We hit the primary endpoint, hit the key secondary endpoint of PFS, OS clearly affected by crossover. We have a solid argument for full approval,” Schuetz said.
Schuetz said Compass expects to request a meeting around the end of May, submit a meeting package roughly 30 days later and potentially meet with the FDA in the first week of August. He said the company would hope to have written feedback from the agency by Labor Day.
Compass is also conducting additional statistical analyses to adjust for crossover, Schuetz said. He cited prior regulatory precedent for post hoc crossover-adjusted analyses and said the company continues to follow patients for overall survival.
Potential Confirmatory Trial Designs
If the FDA were to require a confirmatory study under Accelerated Approval, Schuetz outlined two possible designs. One would be a second-line trial comparing tovecimig plus paclitaxel against FOLFOX, likely conducted outside the United States to avoid crossover from the control arm to commercially available tovecimig plus paclitaxel. Another would be a frontline study adding tovecimig to a regimen such as gemcitabine, cisplatin and durvalumab.
Schuetz said an ongoing single-arm investigator-sponsored study at MD Anderson is evaluating tovecimig in the frontline setting and is generating early safety and efficacy data that could inform future trial design.
ASCO Update Planned for CTX-8371
Compass also plans to present data for CTX-8371, its PD-1/PD-L1 bispecific program, at the American Society of Clinical Oncology meeting. Schuetz said the poster will include a full analysis of the dose-escalation cohort, full safety data and updated early efficacy signals.
He said the drug has been “incredibly well-tolerated” with no dose-limiting toxicities. The presentation is expected to include PET scans from a patient with Hodgkin’s lymphoma who experienced a deep metabolic partial response, as well as durability updates for responses in Hodgkin’s lymphoma and triple-negative breast cancer.
According to Schuetz, a triple-negative breast cancer patient has remained on drug for more than a year with a continuing deep and durable response. Cohort expansions have begun in non-small cell lung cancer, triple-negative breast cancer and Hodgkin’s lymphoma, with more than 10 patients enrolled, though efficacy updates from the expansion cohorts are not expected at ASCO because of scan timing.
Combination Strategy and Balance Sheet
Schuetz said Compass does not plan to wait for all single-agent expansion data before starting combination work. He said the company is interested in combining CTX-471 with tovecimig, citing the therapeutic rationale of combining checkpoint inhibition with angiogenesis disruption.
The company also discussed CTX-10726, a PD-1/VEGF-A bispecific antibody. Schuetz said Compass selected hepatocellular, gastric, renal cell and endometrial cancers for its Phase 1 study because those indications have shown efficacy signals for checkpoint inhibitors or angiogenesis inhibitors. He said the company is trying to think “more creatively” about clinical indications rather than focusing on non-small cell lung cancer, where many other drugs in the class are being developed.
Schuetz said Compass ended the first quarter with $195 million in cash, which he said provides runway into 2028. He said that funding supports preparation for a potential U.S. tovecimig launch next year, the cohort expansion study for A371, an NCAM-positive basket study for CTX-471 and the full Phase 1 program for CTX-10726.
About Compass Therapeutics (NASDAQ:CMPX)
Compass Therapeutics, Inc is a clinical‐stage biotechnology company dedicated to the discovery and development of novel immuno‐oncology therapies. Headquartered in Cambridge, Massachusetts, the company focuses on engineering monoclonal antibody candidates designed to enhance T cell–mediated anti‐tumor responses. Compass leverages proprietary antibody platforms to identify and optimize biologics that modulate immune checkpoint pathways and the tumor microenvironment.
The company’s lead programs include CTX-471, a bispecific antibody targeting both PD-1 and PD-L1 checkpoints, and DSP107, a CD47‐SIRPα pathway modulator aimed at disrupting “don’t eat me” signals on cancer cells.
