お知らせ • May 05
Compass Therapeutics, Inc. Reports Positive Interim Phase 2 Data of CTX-009 in Combination with Paclitaxel in Biliary Tract Cancers
Compass Therapeutics, Inc. reported additional interim results from a Phase 2 study of CTX-009 in combination with paclitaxel in patients with biliary tract cancers (BTC). The data show that: CTX-009 demonstrated a 42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation CTX-009 demonstrated anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients CTX-009 was well-tolerated and preliminary safety profile is consistent with prior studies. The Phase 2 study has a Simon Two-Stage adaptive design where three PRs among the first 21 patients enrolled in the first stage of the study will advance the study to the second stage. In November 2021, Compass reported that there were five PRs observed among the first 17 evaluable patients, and therefore, the criteria to advance the study to its second stage was met. The study is currently being conducted at four leading medical centers in Korea. In the United States, an IND was opened in January of 2022 and first patient dose is projected to take place in early Third Quarter 2022. Enrollment All patients enrolled in the study had BTC, classified into four subgroups: intrahepatic cholangiocarcinoma (37.5%), extrahepatic cholangiocarcinoma (12.5%), gallbladder cancer (29.2%) and ampullary cancer (20.8%). As of the data cut-off date April 14, 2022, 24 patients were enrolled and dosed with at least one cycle of CTX-009 and paclitaxel, and 22 were evaluable for response. All patients enrolled in the study have advanced BTC; 45.8% of the patients received one prior therapy and 54.2% of the patients received at least two prior therapies. Almost all patients (95.8%) received gemcitabine/cisplatin. Patients had a median age of 61.5 years, an ECOG performance status of 0 (54.2%) or 1 (45.8%). Preliminary Activity Data CTX-009 exhibited a 42% ORR based on 10 patients with PRs, including nine confirmed PRs by RECIST 1.1 and one PR pending confirmation. Two patients were not evaluable for the purpose of efficacy, and 22 of the 24 patients have had stable disease or better observed leading to a CBR of 92%. As of the cutoff date, seven patients were continuing to receive treatment, including five patients who had been on treatment for over nine months. Preliminary Safety Data CTX-009, in combination with paclitaxel, continues to be well tolerated, consistent with the Phase 1 studies, with hypertension and neutropenia being the most common events related to CTX-009 and paclitaxel, respectively. Of the 24 subjects enrolled in the study, all subjects had at least one AE related to CTX-009 and/or paclitaxel. The most common adverse events (all Grades) occurring in at least three patients were anemia (12.5%), asthenia (25.0%), fatigue (16.7%), edema (16.7%), pyrexia (16.7%), neutropenia (54.2%), thrombocytopenia (20.8%), headache (16.7%), proteinuria (20.8%), dysphonia (12.5%), dyspnea (25%), epistaxis (33.3%), pulmonary hypertension (16.7%, all Grade 1) and hypertension (50.0%). Grade 3 or greater treatment-emergent adverse events (TEAE) occurring in more than one patient include neutropenia (n=12; 50.0%), hypertension (n=4; 16.7%), anemia (n=3; 12.5%) and thrombocytopenia (n=2; 8.3%); all TEAEs were manageable with standard treatment. The Phase 2 trial was designed as a prospective, multi-center, open-label, Simon Two-Stage adaptive design trial to evaluate the use of CTX-009 in combination with paclitaxel for the treatment of patients with BTC. The study enrolled patients with advanced, unresectable, metastatic or recurrent biliary tract cancer with an ECOG performance status of 0 or 1. The initial phase of the trial was conducted in Korea and enrolled 24 subjects at four leading medical centers. All subjects received bi-weekly doses of 10 mg/kg of CTX-009, and paclitaxel, dosed at 80 mg/m2 weekly every three out of four weeks. The primary endpoint for the study is ORR, based on the proportion of subjects whose best overall response is assessed to be Complete Response (CR) or Partial Response (PR) per Independent Radiology review. Secondary outcome measures include assessments of several standard measures of disease progression.