Global biotech company Immutep (ASX: IMM) has announced that its Chinese partner EOC Pharma will begin a Phase II clinical trial to evaluate the efficacy and safety of its lead drug eftilagimod alpha in the treatment of metastatic breast cancer.
The study follows encouraging results from an ongoing AIPAC Phase IIb (Active Immunotherapy Paclitaxel) trial that began earlier this year and aims to use the drug in combination with paclitaxel, a taxane standard for chemotherapy drugs Treatment of a wide variety of cancers, to be assessed.
EOC Pharma is the exclusive licensee of efti for the Chinese market and has to finance the development of the drug in China under its license agreement with Immutep.
The Phase II clinical trial will enroll up to 152 patients in 20 clinical sites to evaluate the effects of eftilagimod alpha in combination with paclitaxel chemotherapy in HER2-negative / HR-positive metastatic breast cancer patients following endocrine therapy show progression.
Breast cancer is the most common cancer in Chinese women with more than 1. 6 million people are diagnosed and 1. 2 million people die from the disease every year.
Marc Voigt, Chief Executive Officer of Immutep, said the EOC process will build on encouraging data from the AIPAC study.
« AIPAC marks an important milestone for [us] and strengthens our confidence that Efti can be of benefit to many cancer patients, including those with metastatic breast cancer, » he said.
Mr. Voigt confirmed that the EOC had received positive scientific advice from China’s National Medical Products Administration that enabled the first patient to be enrolled and dosed in the study in the first quarter of 2021.
The efficacy results published today from the AIPAC study have shown a « statistically significant overall survival benefit ». in metastatic breast cancer patients who are known to be insensitive to therapy with immune checkpoint inhibitors.
The results showed a promising and improving trend in overall survival in the general population. and a mean survival benefit of 2. 7 months after using Efti plus chemotherapy versus chemotherapy plus placebo.
A survival benefit greater than 7. 1 month after efti plus chemotherapy was shown in patients under 65 years of age (the 66 represented). 7% of the Efti group), while those with a low starting monocyte count (21. 9% of the group) experienced more than 9. 4 months survival benefit.
The study also showed a statistically significant increase in CD8 (cytotoxic) T cells in patients treated with Efti plus chemotherapy, which was correlated with prolonged overall survival and pharmacodynamic activity and proof of concept for the Efti mode indicated action.
Mr. Voigt said improving overall survival is a key endpoint in evaluating the benefits of new cancer drugs.
« ???? In particular, in this study we saw a significantly larger overall survival benefit than the [progression-free survival benefit]. However, we do know that this is not uncommon for some immunotherapies where it can take time for the body. « The immune system should be strengthened and offer therapeutic benefits. he said.
â ???? We are very encouraged by these first [AIPAC] results which â ???? subject to ongoing data collection â ???? Ensuring a registration perspective and regulatory interactions on what will hopefully be an important new class of drugs. â ????
The data supports Immutep’s longstanding belief that Efti can provide significant benefit to patients in a range of cancers by pushing the gas. on the body’s immune system.
???? Through this mechanism, efti helps a large proportion of the patients in the AIPAC study with Her2-negative / HR-positive metastatic breast cancer, which is typically a non-immunogenic cancer and is significantly less responsive to modern diseases. Immune checkpoint inhibitor therapies? Mr. Voigt said.
???? As such, chemotherapy remains the standard of care in many cases and there remains a great unmet medical need. â ????
Immutep, Stock, ASX, ASX: IMM, NASDAQ: IMMP, metastatic breast cancer
World News – USA – Immutep’s Chinese partner launches phase II clinical trial in patients with metastatic breast cancer
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