Sacituzumab Govitecan Demonstrates Durable Responses in Metastatic TNBC

Excerpt:

“Sacituzumab govitecan (IMMU-132) was well tolerated and demonstrated early and durable responses in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC), according to the results of a recent phase I/II study published in the Journal of Clinical Oncology.

“Sacituzumab govitecan is an antibody–drug conjugate that targets Trop-2, which is expressed in more than 90% of TNBCs, by selectively delivering SN-38, the active metabolite of irinotecan. It was granted a breakthrough therapy designation by the FDA in February 2016 for the treatment of patients with mTNBC, following at least 2 treatments for metastatic disease.”

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Durable Responses Seen With Sacituzumab Govitecan in NSCLC

Excerpt:

“The antibody-drug conjugate sacituzumab govitecan (IMMU-132) was well-tolerated and produced a median duration of response of 6.0 months in previously treated patients with metastatic non–small cell lung cancer (NSCLC), according to results from a single-arm, multicenter trial.

“The results, which were published online in the Journal of Clinical Oncology, showed a median progression-free survival of 5.2 months (95% CI, 3.2-7.1) and median overall survival of 9.5 months (95% CI, 5.9-16.7) in the intent-to-treat population. The clinical benefit rate of 43%.”

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Novel Antibody-Drug Conjugate Targets Triple-Negative Breast Cancer

Excerpt:

“The antibody-drug conjugate sacituzumab govitecan (IMMU-132) produced high objective response rates, many of them quite durable, in a multicenter study of heavily pretreated patients with metastatic triple-negative breast cancer, presented at the 2016 San Antonio Breast Cancer Symposium.

“Trop-2 is a calcium signal transducer that drives tumor growth and has shown promise as a novel therapeutic target in triple-negative breast cancer, since the majority of these tumors express Trop-2. Sacituzumab govitecan targets Trop-2 and selectively delivers high doses of SN-38, the active metabolite of irinotecan that is 1,000 times more active than the parent compound. In addition to drug delivery, sacituzumab govitecan potentially also activates antibody-dependent cell-mediated cytotoxicity.”

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Sacituzumab Govitecan Elicits Durable Responses for Pretreated TNBC

Excerpt:

“Treatment with sacituzumab govitecan (IMMU-132) was well-tolerated and induced durable responses, some lasting longer than 1 year, for heavily pretreated patients with metastatic triple-negative breast cancer (TNBC), according to findings from an ongoing phase I/II study presented at the 2016 San Antonio Breast Cancer Symposium (SABCS).

“In the single-arm trial, the confirmed objective response rate (ORR) was 30% with sacituzumab govitecan, and the duration of response was 8.9 months (95% CI, 6.1-11.3). The median progression-free survival was 6.0 months (95% CI, 5.0-7.3) and the median overall survival was 16.6 months (95% CI, 11.1-20.6).”

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New Research on Triple Negative Breast Cancer Emerges at ASCO 2016


The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.

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Sacituzumab Govitecan Shows Promise for Metastatic NSCLC

Excerpt:

“Treatment with sacituzumab govitecan induced objective responses and appeared tolerable in patients with metastatic non–small cell lung cancer who had received first-line platinum-based therapy, according to the results from an expansion cohort of a phase 1/2 study presented at the ASCO Annual Meeting.

” ‘This therapy showed efficacy for squamous and non-squamous patients as well as for patients with prior PD-1/PD-L1 therapy,’ D. Ross Camidge, MD, PhD, professor in the division of medical oncology and Joyce Zeff chair in lung cancer research at University of Colorado Anschutz Medical Campus, said during a presentation.

Sacituzumab govitecan (IMMU-132, Immunomedics) is an antibody drug conjugate comprised of SN-38 — the active metabolite of irinotecan, a topoisomerase inhibitor — conjugated to an anti–Trop-2 humanized monoclonal antibody.”

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Immunomedics’ Sacituzumab Govitecan (IMMU-132) Demonstrates Efficacy and Safety in Non-Small-Cell Lung Cancer Patients With Multiple Prior Treatments, Including Immuno-Oncology

Excerpt:

Immunomedics, Inc., (IMMU) today announced that sacituzumab govitecan (IMMU-132), its lead investigational antibody-drug conjugate (ADC), shrank tumors by 30% or more initially in 26% (12/46) of evaluable patients with metastatic non-small-cell lung cancer (NSCLC), with a later confirmed overall objective response rate (ORR) of 13%, in accordance with RECIST 1.1 criteria. For the patients with confirmed responses, the duration of response (DOR) was 9 months.

“Interim median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95% confidence interval [CI]; 3.4, 6.9) and 10.5 months (95% CI; 5.8, 10.5), respectively. Significant tumor shrinkage and disease stabilization was observed in both adenocarcinoma and squamous cell carcinomas, the two major subtypes of NSCLC, and in patients who had failed previous anti-PD-1/PD-L1 therapy.”

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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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FDA Assigns Sacituzumab Govitecan Breakthrough Designation for TNBC

“The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.

“The designation, which will expedite the development and review of sacituzumab govitecan in TNBC, is based on a phase II trial in which the therapy induced a response rate of 31% in heavily pretreated patients with metastatic TNBC.

“ ‘We believe breakthrough therapy designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,’ Cynthia L. Sullivan, president and chief executive officer, of Immunomedics, said in a statement. ‘We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the special protocol assessment agreement that was already granted by the FDA,’ she added.”