Oncolytics Biotech (ONCY) Announces Positive Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial
Oncolytics Biotech (NASDAQ:)® Inc. (ONCY) today announced positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The results are published in an abstract accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from
BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.
Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed ≥50% improvements on the trial’s primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO abstract cut-off date (
“BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone,” said Dr.
A detailed summary of BRACELET-1’s data are shown below. Updated results as of a May cut-off date will be featured in an oral presentation at the ASCO meeting on
Response and Progression-free Survival (
Paclitaxel (PTX) Monotherapy (n=15) |
PTX + Pelareorep (n=16) |
PTX + Pelareorep + Avelumab (n=17) |
|
ORR at Week 161 |
3 (20 %) |
5 (31.3 %) |
3 (17.6 %) |
Disease Control Rate at Week 16 (CR+PR+SD) |
7 (46.7 %) |
10 (62.5 %) |
12 (70.6 %) |
mPFS (months)1 |
6.4 (95% CI: 2.0, NR) |
9.6 (95% CI: 6.5, NR) |
7.5 (95% CI: 3.8, NR) |
6-month PFS Rate |
62.5% (95% CI: 27.6%, 84.2%) |
92.9% (95% CI: 59.1%, 99%) |
73.2% (95% CI: 42%, 89.4%) |
1. Three patients who withdrew consent prior to starting therapy and two patints who discontinued treatment after week 1 were considered non-responders and censored for PFS CI: Confidence interval; CR: Complete response; PR: Partial response; SD: Stable disease; NR: Not reached |
Biomarker and Safety
- A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab)
- Pelareorep displayed an acceptable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients
Dr.
Details on the upcoming ASCO oral presentation on BRACELET-1 are shown below.
Title: BRACELET-1 (PrE0113): Inducing an Inflammatory Phenotype in Metastatic HR+/HER2- Breast Cancer with the Oncolytic Reovirus Pelareorep in Combination with Paclitaxel and Avelumab
Abstract Number: 1012
Session Type: Clinical Science Symposium
Session Title: The Dr.
Session Date and Time:
A copy of slides from the ASCO presentation will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.
This story originally appeared on Investing