Despite ASCO Mishap, Data Still Intriguing for Sacituzumab Govitecan in TNBC

Excerpt:

“Sacituzumab govitecan (IMMU-132) had an objective response rate (ORR) of 33% in pretreated patients with triple-negative breast cancer (TNBC), according to updated findings from a phase II study reported by Immunomedics, the manufacturer of the antibody-drug conjugate.

“The results were originally scheduled to be presented at the 2016 ASCO Annual Meeting; however, the study was excluded from the conference when ASCO became aware that its meeting embargo had been violated when the chairman of Immunomedics reported the results at a conference in April. The ASCO exclusion did not question the quality of the research findings, according to a statement from Immunomedics.”

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ASCO 2016: New Antibody-Drug Conjugate Shows Early Promise in Small Cell Lung Cancer

Excerpt:

“Early findings from a first-in-human clinical trial showed that the antibody-drug conjugate rovalpituzumab tesirine (Rova-T) shows promising efficacy against recurrent small cell lung cancer (SCLC). The treatment, which combines a novel anti-DLL3 antibody with a powerful anticancer agent, halted tumor growth in 89% of patients with high levels of DLL3 in the tumor and shrank tumors in 39%.

“The study by Rudin et al was presented today at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8505).

“ ‘We’ve seen too few successes in recent years for small cell lung cancer, which makes these early signs of efficacy all the more encouraging,’ said lead study author Charles M. Rudin, MD, PhD, a medical oncologist and Chief of Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center in New York. ‘Although these results are preliminary, rovalpituzumab tesirine seems to be the first targeted therapy to show efficacy in small cell lung cancer, and we may have identified DLL3 as the first predictive biomarker in this disease.’ ”

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Big Changes Coming in Treatment of Triple-Negative Breast Cancer

“The treatment paradigm for patients with triple-negative breast cancer is set to undergo a dramatic transformation, as standard chemotherapeutic approaches are perfected and novel antibody-drug conjugates are developed.

“The treatment paradigm for patients with triple-negative breast cancer (TNBC) is set to undergo a dramatic transformation, as standard chemotherapeutic approaches are perfected and novel antibody-drug conjugates (ADCs) are developed. Kimberly Blackwell addressed this topic at the 2015 Chemotherapy Foundation Symposium, a meeting of over 1,000 oncologists and oncology professionals in New York City in November.

“ ‘I think we will see significant improvements in triple-negative breast cancer within the next few years,’ said Blackwell, an oncologist at the Duke Cancer Institute. ‘There are two ADCs that I am fairly excited about that are in late stage development.’ “


Small Cell Lung Cancer at ASCO: Some Welcome News


Small cell lung cancer (SCLC) is a fatal disease that has not seen new drug approvals for the last 17 years. Considering the relative success of ‘immune checkpoint inhibitors’ in non-small cell lung cancer (NSCLC), it is not surprising that several abstracts recently presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting were devoted to clinical trials testing these trendy, immune system-boosting drugs in people with SCLC. Continue reading…


New Antibody-Drug Conjugate Shows Early Promise for Patients with Metastatic HER2-Positive Breast Cancer

“An investigational antibody-drug conjugate called MM-302 was safe, tolerable, and showed signs of clinical activity in heavily pretreated patients with metastatic, HER2-positive breast cancer, according to data from a phase I clinical trial presented here at the AACR Annual Meeting 2015, April 18-22.

“MM-302 is an antibody-drug conjugate composed of a HER2-targeted antibody linked to the cytotoxic chemotherapy liposomal doxorubicin. The HER2 antibody delivers the liposomal doxorubicin to HER2-positive breast cancer cells.

” ‘The main purpose of our study was to establish whether MM-302, alone or in combination with trastuzumab, was safe and tolerable for patients with metastatic, HER2-positive breast cancer whose disease had progressed following numerous prior treatments,’ said Patricia LoRusso, DO, associate director of innovative medicine and professor of medicine (medical oncology) at Yale Cancer Center in New Haven, Connecticut, and professor of medicine in the Division of Oncology at Yale University. ‘We found that the drug was well tolerated when administered to these women.’ “


New Drug for Advanced HER2-Positive Breast Cancer Begins Testing in a Clinical Trial

The gist: A clinical trial has begun to test a new treatment for people with HER2-positive breast cancer. The drug is called SYD985. It is being tested in people with locally advanced or metastatic tumors. The first phase of testing will enroll both HER2-positive and HER2-negative cancer patients to test the safety of the drug. The second phase will enroll HER2-positive breast and gastric cancer patients, including patients with low expression of HER2 (HER2 2+).

“Synthon Biopharmaceuticals (‘Synthon’) today announced that the first patients with metastatic solid tumors have commenced treatment with its investigational anti-HER2 antibody-drug conjugate (ADC), SYD985.

“First patients for this trial are being enrolled in leading European oncology centers Radboud University Medical Center (Nijmegen, the Netherlands), the Jules Bordet Institute (Brussels, Belgium) and the Institute of Cancer Research at The Royal Marsden Hospital (London, United Kingdom). The trial will recruit at least 76 patients and more centers are expected to join the trial in 2015.

“This trial is a two part first-in-human Phase I study. In the dose escalation part of the trial, safety and efficacy of SYD985 will be evaluated in patients with locally advanced or metastatic solid tumors of any origin. In the expanded cohort part of the trial, only patients with breast and gastric cancer will be enrolled. The expanded cohorts will include patients currently indicated for HER2-targeted treatment as well as patients with HER2 2+ and HER2 1+ breast cancer for whom there currently is no effective anti-HER2 therapy available.”


Immunomedics Announces Objective Responses in Five Types of Solid Cancer With IMMU-132

“Immunomedics, Inc., (Nasdaq:IMMU) today reported that 71% of patients (34 of 48) with diverse metastatic solid cancers had durable disease stabilization after receiving treatments with the Company’s novel investigational antibody-drug conjugate (ADC), IMMU-132. These include 7 patients (15%) with colorectal, small-cell and non-small-cell lung, esophageal, and triple-negative breast cancers showing partial responses with tumor shrinkage of 30% or more as measured by computed tomography (CT).”

Editor’s note: Scientists have developed a new cancer drug called IMMU-132, which may work in a variety of cancer types. IMMU-132 is an immunotherapy, meaning it boosts a patient’s own immune system to fight cancer. A clinical trial to test the drug in volunteer patients found promising results, including in non-small cell lung cancer (NSCLC) patients.


New Antibody-drug Conjugate Shows Early Promise Against All Forms of Melanoma

“The investigational drug DEDN6526A, which is a new member of a class of drugs called antibody-drug conjugates, was safe, tolerable, and showed hints of activity against different forms of melanoma—cutaneous, mucosal, and ocular—according to results of a first-in-human phase I clinical trial presented here at the AACR Annual Meeting 2014, April 5-9.

“Antibody-drug conjugates consist of an antibody attached to a toxic chemotherapy by a special linker that keeps the chemotherapy inactive. In the case of DEDN6526A, the antibody recognizes the protein endothelin B receptor (ETBR) and the toxic chemotherapy is monomethyl auristatin (MMAE). Infante explained that when administered to the patient, the antibody portion of DEDN6526A recognizes and attaches to ETBR, which is often present at elevated levels on the surface of tumor cells in patients with melanoma. The whole antibody-drug conjugate is then taken up by the cells and MMAE is released from the linker to become active, killing the melanoma cells.”


First Clinical Trial of New Cancer Drug IMGN289 Begins

A phase I clinical trial marks the start of early testing for new cancer drug IMGN289. IMGN289 is a so-called antibody-drug conjugate (ADC). ADCs combine antibodies (immune system proteins designed to bind to specific targets) with chemotherapy drugs to help steer the chemotherapy agents specifically towards tumors and spare healthy tissues. IMGN289 consists of an antibody that binds to EGFR, a protein expressed in many lung cancer tumors, connected to a cell-killing agent called DM1. The trial will study patients with non-small cell lung cancer (NSCLC) and other cancers that express high levels of EGFR. After determining the highest IMGN289 dose that can safely be administered to patients, the study will evaluate the effectiveness of the drug in different patient subgroups.