NCI-MATCH arms fall short in ASCO abstracts

Three arms of NCI’s Molecular Analysis for Therapy Choice (NCI-MATCH) tissue agnostic basket trial will report overall response rates below 10% at this year’s American Society of Clinical Oncology meeting, according to abstracts released late Wednesday.

NCI-MATCH is a Phase II signal-seeking study that assigns patients with solid tumors, lymphomas or multiple myeloma to treatment arms according to molecular alterations in their cancers. According to NCI's website, treatments "will be considered promising if at least 16% of the patients in an arm have tumor shrinkage,” meaning a complete response (CR) or partial response (PR) to treatment.

In an arm evaluating Kadcyla ado-trastuzumab emtansine in patients with HER2-amplified tumors, three (8%) of 37 patients had a PR and 43% had stable disease; no complete responses were reported.

Roche (SIX:ROG; OTCQB:RHHBY) markets Kadcyla, a humanized mAb against HER2 linked to a DM1 cytotoxic agent from ImmunoGen Inc. (NASDAQ:IMGN), to treat metastatic breast cancer. The NCI-MATCH Kadcyla substudy excluded these patients as well as those with gastric adenocarcinomas.

Among 41 patients with fibroblast growth factor receptor (FGFR) aberrations in an arm receiving AZD4547 from AstraZeneca plc (LSE:AZN; NYSE:AZN), two (5%) patients had a PR and 51% had stable disease; there were no CRs.

AZD4547 is an FGFR inhibitor in Phase II testing to treat solid tumors.

There were no objective responses in an arm evaluating taselisib in patients with phosphoinositide 3-kinase (PI3K) catalytic subunit alpha polypeptide (PIK3CA; p110alpha) activating mutations; 27% of the 65 patients enrolled had “prolonged stable disease,” or progression-free survival (PFS) lasting at least six months.

Roche and its Genentech Inc. unit are evaluating the PI3K alpha inhibitor in a Phase III trial to treat HER2-negative advanced or metastatic breast cancer.

Data from the AZD4547 substudy will be reported on June 1. Data from the Kadcyla and taselisib substudies will be reported on June 2.

At least one NCI-MATCH arm has reported a higher response rate. At November’s meeting of the Society for Immunotherapy of Cancer (SITC), NCI-MATCH investigators reported PRs in eight (24%) of 33 patients and stable disease in nine (27%) patients with mismatch repair deficient (dMMR) cancers who received treatment with anti-PD1-mAb Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY).

NCI-MATCH is evaluating 22 therapeutics in 30 molecularly defined groups.