NEW YORK, June 14, 2012 /PRNewswire/ -- Citeline, the world's leading research authority on pharmaceutical clinical trials and drug intelligence, recently reviewed the results presented at the American Society of Clinical Oncology (ASCO) conference held June 1-5, 2012 in Chicago, IL. A new type of targeted therapy was of particular interest to reviewer Daphna Halpern, Citeline's Director of Oncology: Antibody-Drug Conjugates (ADC's). According to Ms. Halpern, "ADC's are looking to be one of the next advancements in cancer drug development."
One of the most promising ADC's that had results presented at the meeting is trastuzumab emtansine (T-DM1) by Roche/Genentech. T-DM1 is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly to the HER2-positive cancer cells. The EMILIA study was the first randomized Phase III study of T-DM1. This study enrolled people with HER2-positive metastatic breast cancer who had previously received treatment with trastuzumab and a taxane chemotherapy and showed a significant and clinically meaningful improvement in PFS (progression free survival) compared with capecitabine and lapatinib. Based on the EMILIA findings, Genentech and Roche shared plans to submit applications for T-DM1 in HER2-positive metastatic breast cancer this year to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
"Over recent years, Citeline's product, Pipeline® has monitored 145 ADC's; 30 of them are currently in active development, "states Ms. Halpern. "We are also monitoring, through the product Trialtrove®, clinical trials for those ADCs that reached clinical development (Phase I-IV)." ADC's are being developed in many types of cancers. Breast cancer has the largest number of clinical trials, and has 5 different drugs in development, followed by non-Hodgkin's lymphoma and head and neck cancer.
Pfizer's inotuzumab ozogamicin, the only other ADC that is currently in phase III development, also had results presented at the meeting. It is in phase III trials for relapsed or refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma. The interim results presented at ASCO were for an ongoing trial in refractory- relapsed ALL patients in which weekly inotuzumab ozogamicin showed activity and an overall response (OR) of 50% thus far.
There were also other ADC's presenting data at the meeting. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC), by Progenics Pharmaceuticals, had interim data revealed for an ongoing phase I trial for metastatic castration-resistant prostate cancer patients previously treated with a taxane.
Gemtuzumab ozogamicin results were presented in two trials. Previously marketed for acute myeloid leukemia (AML) but withdrawn following a confirmatory post approval clinical trial that did not show improvement in clinical benefit and after a greater number of deaths occurred in the group who received it. Results were presented in a phase II study being conducted by the National Cancer Institute (NCI) and the Southwest Oncology Group (SWOG) and showed that the combination with hydroxyurea and azacitidine is associated with a low induction mortality. A second phase II study from the MD Anderson Cancer Center concluded that the effect of fludarabine, cytarabine, filgrastim, and gemtuzumab ozogamicin (FLAG-GO) is a highly effective regimen and has resulted in high rate of relapse-free survival in patients with newly diagnosed patients with core-binding factor AML.
Notably ADC's are comprised of an antibody that is linked to a cytotoxic agent. The cytotoxic agents are designed to eliminate fast-growing cancer cells, but they can also harm healthy proliferating cells, which cause side effects. Therefore, linking an ADC with a cytotoxic agent may allow chemotherapy to directly target the cancer cell and avoid harming the health cells reducing the side effects. "Due to this unique quality, it is not surprising that drug companies are exploring ADC's" concludes Ms. Halpern.
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