Study involves patients with advanced common cancers and solid tumours
Exelixis has announced promising initial results from the ongoing dose-escalation stage of JEWEL-101 – a phase 1 study evaluating XB002, the company’s next-generation tissue factor-targeting antibody-drug conjugate.
The data was presented at ENA 2022 during the Symposium on Molecular Targets and Cancer Therapeutics hosted by the European Organisation for Research and Treatment of Cancer, the National Cancer Institute and the American Association for Cancer Research.
JEWEL-101 has enrolled several patients with advanced solid tumours for which therapies are unavailable, ineffective or intolerable. The most common types of cancer for these patients were pancreatic cancer, colorectal cancer, cervical cancer and prostate cancer and median age was 63 years.
No objective responses have been observed, while three patients with stable disease remain on treatment with XB002 – one each with metastatic castration-resistant prostate cancer, appendiceal adenocarcinoma and pancreatic adenocarcinoma, at treatment durations of 42 weeks, ten weeks and seven weeks, respectively.
One additional patient with uterine carcinosarcoma who achieved stable disease as the best response discontinued XB002 at 15 weeks. In the upcoming cohort-expansion stage, the efficacy of XB002 will be further evaluated as a single agent and in combination with nivolumab.
“Following promising preclinical data, it is encouraging to see that XB002 was well-tolerated across multiple dose levels with a pharmacokinetic analysis supporting the ability of XB002 to remain stable after infusion and reach its target before releasing its cytotoxic payload,” reflected Susanna Ulahannan, assistant professor of medicine in the section of oncology at the University of Oklahoma College of Medicine.
“As the dose-escalation phase progresses, and we initiate enrolment into tumour specific cohorts, I look forward to learning more about how XB002 may benefit people with advanced solid tumours, in particular in tumour types with high unmet need,” she added.
“We are pleased to present the first clinical profile of XB002 at ENA 2022, representing an important milestone for our first biologic in clinical development,” concluded Vicki Goodman, executive vice president at Exelixis. “We are eager to proceed to the expansion cohort stage of JEWEL-101 once the recommended dose is determined, as we aim to further understand the activity of this molecule as a potential new treatment for people who have difficult-to-treat tumours with limited treatment options.”