Immunotherapy company Immutep (ASX: IMM) has announced what it describes as promising overall survival data from a breast cancer study of its Eftilagimod Alpha (efti) and that its Chinese partner, EOC Pharma, is launching a new Phase 2 clinical trial will start with up to 152 patients.
The encouraging results come from an ongoing Phase 2 study (AIPAC) in which Efti combined with paclitaxel chemotherapy versus a combination of placebo and paclitaxel chemotherapy in patients with HER2 negative / HR positive metastatic breast cancer (HR MBC) is assessed. .
The company said initial results show an improving overall trend in overall survival (OS) with a median of 2. 7 months from Efti plus chemotherapy versus chemotherapy plus placebo.
It was indicated that the Efti combination had a statistically significant OS benefit in predefined patient groups.
It was 7. 1 month survival benefit of Efti with chemotherapy for patients under 65 years of age. It was 9. 4-month survival benefit of Efti with chemotherapy in patients with low starting monocyte counts.
According to Marc Voigt, CEO of Immutep, “AIPAC is an important milestone for Immutep and reinforces our confidence that efti will be beneficial for many cancer patients, including those with metastatic breast cancer. In particular, in this study we found a more substantial OS benefit than the PFS benefit. However, we find that this is not uncommon with some immunotherapies, where it may take time for the body’s immune system to be strengthened and provide therapeutic benefit.
“We are very encouraged by these initial OS results, which, subject to ongoing data collection, warrant a registration perspective and regulatory interactions on what will hopefully be an important new class of drugs. ”
EOC Pharma is the exclusive licensee of Immutep’s efti for the Chinese market. As part of the agreement with Immutep, the company will make further milestone payments to the company if efti reaches certain development milestones as well as unspecified license fees for sales and also has to finance the Chinese development of efti.
The new study is similar to the AIPAC study. The EOC Pharma trial will be a randomized, double-blind, placebo-controlled, phase 2 clinical trial with study endpoints including progression-free survival, overall survival, and overall response rate.
It is expected to take place over a period of 24 months at 20 clinical trial sites in China and evaluate efti in combination with paclitaxel in HER2-negative / HR-positive metastatic breast cancer patients who have progressed after endocrine therapy.
Xiaoming Zou, CEO of EOC Pharma, said, “Breast cancer is the most common cancer in Chinese women today, at more than 1. 6 million people are diagnosed and 1. 2 million people die from the disease every year. It is very important that we find new ways to improve paclitaxel chemotherapy, which continues to be a standard for the treatment of HER2-negative / HR-positive metastatic breast cancer patients. Immutep’s recent encouraging AIPAC preliminary results give us hope that we can boost the body’s immune system to provide better results for patients. ”
Marc Voigt added, “EOC Pharma shares our growing excitement about the potential for combining Efti with paclitaxel chemotherapy for metastatic breast cancer. Our ongoing AIPAC study evaluating the same combination already has very encouraging data, including a statistically significant survival benefit of 7. 1 month for patients under 65 years of age and 9. 4 months for patients with a low starting monocyte count. The new study by EOC Pharma in China brings this innovative new treatment much closer to the metastatic breast cancer patient market. ”
Immutep, ASX, ASX: IMM, Stock, Metastatic Breast Cancer, NASDAQ: IMMP, Eftilagimod alpha
World News – CA – Immutep updates on AIPAC breast cancer study and announces a new study
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