Curis (NASDAQ:CRIS) reported updated clinical data for emavusertib in primary central nervous system lymphoma, or PCNSL, and said enrollment momentum is building in a separate chronic lymphocytic leukemia study, according to remarks on the company’s emavusertib update call.
James Dentzer, Curis’ president and chief executive officer, said the company is presenting updated results from the TakeAim Lymphoma study, which is evaluating emavusertib in combination with ibrutinib in patients with relapsed or refractory PCNSL, a rare and difficult-to-treat subtype of non-Hodgkin lymphoma.
Updated PCNSL Data
As of a July 1, 2026, data cutoff, Dentzer said the overall response rate in BTK inhibitor-naive patients was 86%, with six of seven patients achieving a response. Among evaluable patients, defined by the company as those able to complete at least one cycle of treatment, the response rate was 100%, or five of five patients.
Dentzer said previously published studies of BTK inhibitors in PCNSL have generally shown response rates of 40% to 70%. He said the company believes the combination of emavusertib and a BTK inhibitor “appears to be better than BTKI alone.”
In BTK inhibitor-experienced patients, whose disease had progressed while taking a BTK inhibitor, Dentzer said the response rate was 26%, with 10 of 39 patients responding. Among evaluable patients in that group, the response rate was 33%, or 10 of 30 patients.
Dentzer said patients who have failed both frontline therapy and BTK inhibitor treatment have a poor prognosis, with many proceeding to hospice or best supportive care. He said the updated results continue to support the potential for accelerated approval submissions in the U.S. and Europe, and the company expects to complete enrollment in the registrational dataset in 2027.
Regulatory Strategy Discussed
During the question-and-answer portion of the call, Srikripa Devarakonda of Truist asked about the number of BTK inhibitor-experienced patients required for the registrational dataset and regulatory expectations for response rates.
Dentzer said Curis had discussions with the U.S. Food and Drug Administration and the European Medicines Agency regarding the salvage-line PCNSL population, where he said there are no approved options and no consistent treatment guideline after failure of frontline therapy and BTK inhibitors.
He said the company discussed a statistical lower bound of 10% for response rate with regulators. Dentzer said that if Curis observes a response rate of 20% or higher, the company would need roughly 45 to 60 patients to achieve a p-value of less than 0.05. He said both the FDA and EMA considered that dataset size reasonable, while also noting that safety would need to be addressed.
On duration of response, Dentzer referenced the iLOC study by Carole Soussain in Paris and said progression-free survival in BTK inhibitor patients was two months in that study. He said Curis has shown four to six months so far, with some patients remaining on drug for more than two years and approaching three years.
CLL Study Enrollment
Dentzer also discussed Curis’ work in chronic lymphocytic leukemia, where he said BTK inhibitors have become standard of care but typically produce partial responses rather than complete remissions. As a result, he said many patients remain on chronic treatment and may develop BTK inhibitor-resistant mutations before disease progression.
Curis is testing whether adding emavusertib to a BTK inhibitor regimen can produce deeper responses by blocking two pathways: the B-cell receptor pathway through BTK inhibition and the toll-like receptor pathway through emavusertib. Dentzer said the company is studying patients on BTK inhibitor monotherapy who have achieved partial remission but have not achieved complete remission or undetectable minimal residual disease.
He said Curis recently announced 11 activated clinical sites and six consented patients in the CLL study. Since then, four additional patients have consented, bringing the total to 10. Dentzer reiterated guidance that the company expects to dose the first five patients by the end of the month and raised its guidance for year-end clinical data from five patients to five to 10 patients.
Further Questions on Development Plans
Yale Jen of Laidlaw & Company asked whether Curis could consider filing in both first-line and second-line PCNSL, given the data in BTK inhibitor-naive and experienced patients. Dentzer said the BTK inhibitor-naive dataset remains small, with five evaluable patients and seven in the intent-to-treat group, and said it would be premature to suggest moving into frontline therapy.
Dentzer said Curis’ broader thesis is that emavusertib could be added to BTK inhibitor regimens across non-Hodgkin lymphoma indications where BTK inhibitors are used, including PCNSL, CLL, Waldenstrom’s, mantle cell lymphoma and marginal zone lymphoma.
Sara Nik of H.C. Wainwright asked about enrollment in Part C of the PCNSL study. Dentzer said the company’s current emphasis is the registrational dataset in BTK inhibitor-experienced patients, while the randomized study in BTK inhibitor-naive patients is intended to support full approval after an accelerated approval filing.
Boris Peaker of JonesTrading asked about BTK resistance mechanisms and the role of mutations such as C481S and MYD88. Ahmed Hamdy, Curis’ chief medical officer, said emavusertib works through the toll-like receptor IRAK4 pathway and may augment BTK inhibition by targeting NF-κB signaling. Dentzer added that blocking the toll-like receptor pathway is independent from the B-cell receptor pathway targeted by BTK inhibitors.
Dentzer closed the call by thanking patients, families, Curis employees, partner Aurigene, investigators and the academic community for their collaboration and support.
About Curis (NASDAQ:CRIS)
Curis, Inc is a biotechnology company focused on the discovery, development and commercialization of targeted small molecule and antibody therapeutics for the treatment of cancer. The company’s research centers on exploiting key signaling pathways and tumor microenvironment interactions to develop compounds with the potential to address unmet medical needs. Curis’ proprietary pipeline includes multiple programs at various stages of clinical and preclinical development, reflecting its emphasis on innovative oncology drug candidates.
Among Curis’ lead assets is CA-4948, an oral inhibitor of interleukin-1 receptor–associated kinase 4 (IRAK4) partnered with Ikena Oncology, which is being evaluated in hematologic malignancies and solid tumors.
