Announced this week by the SOLTI academic Breast Cancer Research Group, the ACROPOLI phase II open-label single arm, non-randomized, multicenter study* has enrolled First Patient In. This multicenter Basket trial (SOLTI-1904) will include a total of 141 patients from across 10 Spanish hospitals and is led by the Vall d’Hebron University Hospital (HUVH) and the Hospital Clínic in Barcelona.
Promoted by the SOLTI Breast Cancer Research Group, the beauty of this trial lies in its design. This pioneering Basket will enable the investigators to assess the efficacy and safety profile of a novel anti–PD-1 antibody, spartalizumab, across 29 different tumor types with high PD1 expression levels, independently of tumor histology.
PD1 expression levels will be identified by molecular prescreening, performed centrally at the Hospital Clínic, Barcelona, under the direction of Aleix Prat, Head of the Medical Oncology Department, President of SOLTI, and Principal Investigator of ACROPOLI. The investigators, including VHIO’s Director, Josep Tabernero as co-Principal Investigator, and Cristina Saura who heads our Breast Cancer Group, will also evaluate the predictive value of PD-1 status as a biomarker to more precisely match patients to treatments across several different cancers.
This two-year study, powered by the pharmaceutical company Novartis, will include two cohorts; the first will include a total of 111 patients identified with PD1-high metastatic tumors, and the second will enroll 30 patients with PD1-low advanced solid tumors to establish cases in which treatment with spartalizumab fails to demonstrate clinical benefit.
“To improve outcomes for our patients, we must seek to more precisely stratify those patients who would be most likely to benefit from novel immune-based therapies, and those who will not. Basket designs are enabling us to more swiftly assess the efficacy of selected anti-cancer therapies in real time, across multiple tumor types at the same time, as well as identify more robust, predictive biomarkers of response,” said Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital (Vall d’Hebron Barcelona Hospital Campus).
“The scope of ACROPOLI’s basket design will also facilitate the study of less common cancer types, for which treatment options are often limited. This biomarker might guide us to more precisely match a subset of patients to novel immunotherapies based on the genetic specificities of their individual tumors,” added Cristina Saura, a SOLTI Board Member.
VHIO’s participation in this national multi-center trial is illustrative of its leading role in designing and developing a new generation of data rich, dynamic studies in oncology. Specifically, VHIO promotes biomarker-drug co-development towards more precisely tailoring therapies to each disease setting, each individual patient.
“These ‘smarter’ Basket designs enable investigators to identify the optimal treatment for the right patient, at the right time, and promise to overcome the rigidity and limitations of traditional clinical trials,” concluded Josep Tabernero.