Date: 2017-05-18
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Roche (Switzerland)
Product: CEA-TCB (RO6958688; RG7802)
Action
mechanism:
- bispecific antibody. CEA-TCB is a novel T-cell bispecific antibody being investigated for the treatment of carcinoembryonic antigen (CEA)-expressing solid tumours. As CEA is overexpressed in a variety of cancers, including colorectal cancer (CRC), CEA-TCB has the potential to work in a broad range of solid tumours. CEA-TCB uses a novel 2-to-1 molecular design. It is engineered to bind simultaneously with one arm to CD3 on T-cells and with two arms to CEA on tumour cells, bringing T-cells into close proximity to the cancer cells. This leads to T-cell activation and subsequent tumour cell killing.
Disease: carcinoembryonic antigen (CEA)-positive solid tumours, including microsatellite stable (MSS) metastatic colorectal cancers (mCRC) that overexpress CEA and progressed after at least two prior chemotherapy regimens
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On May 18, 2017, Roche announced results from two Phase I studies evaluating the novel cancer immunotherapy CEA-TCB (RO6958688; RG7802). CEA-TCB was studied in patients with carcinoembryonic antigen (CEA)-positive solid tumours, including microsatellite stable (MSS) metastatic colorectal cancers (mCRC) that overexpress CEA and progressed after at least two prior chemotherapy regimens. These results of these Phase I studies will be presented at the 2017 American Society for Clinical Oncology (ASCO) Annual Meeting.
- The studies demonstrated encouraging anti-tumour activity of CEA-TCB as a monotherapy, which was further enhanced in combination with Tecentriq® (atezolizumab).
- In the monotherapy, out of 31 patients with mCRC treated with CEA-TCB doses of 60mg or above, 14 patients (45%) showed either partial response (n=2, 6%) or stable disease (n=12, 39%). For the combination, of 25 patients treated with doses of 5–160mg of CEA-TCB, 11 patients with MSS mCRC were treated at doses shown to induce tumour lesion inflammation (80 and 160 mg). Nine of these patients (82%) showed either a partial response (n=2, 18%) or stable disease (n=7, 64%) in this difficult-to-treat population.
- CEA-TCB showed favourable pharmacokinetics and a manageable safety profile in both monotherapy and combination therapy with Tecentriq®. Including all adverse events (AEs) in both studies, the majority of AEs were Grade 1–2, with 7.9% being Grade 3 or higher in the monotherapy trial and 8.1% being Grade 3 or higher in the combination trial. Two treatment-related AEs with severity greater than grade 3, (one Grade 4, one Grade 5), occurred in the monotherapy dose escalation at the highest dose level, which exceeded the maximum tolerated dose (MTD) in cycle.
- A summary of the Phase I results to be presented at ASCO are provided below.
- Study 1: 80 patients (MSS mCRC: 70) treated; 31 available for efficacy evaluation at data cut-off
Study 2: 45 patients (MSS mCRC: 35) treated; 25 available for efficacy evaluation at data cut-off
-
Efficacy and safety results
Is
general: Yes
