|Delayed - 10/22 04:00:00 pm|
Immunomedics : Trodelvy™ Significantly Extends Survival in Phase 3 ASCENT Study of Metastatic Triple-Negative Breast Cancer
|09/19/2020 | 10:31am|
Trodelvy significantly reduced the risk of death by 52 percent, with a median overall survival (OS) of 12.1 months compared to 6.7 months for standard single-agent chemotherapy
Trodelvy is the first ADC to significantly improve OS in metastatic triple-negative breast cancer (mTNBC)
sBLA for full approval to be submitted in fourth quarter 2020 under RTOR process
Company to host conference call and webcast today at 2:00 p.m. Eastern Time
“The randomized Phase 3 study results confirm that sacituzumab govitecan should be considered as a new standard of care in patients with third-line mTNBC,” stated
Despite having received a median of four prior anticancer regimens, patients treated with Trodelvy in the ASCENT study showed a statistically significant and clinically meaningful improvement in OS with a median of 12.1 months (95% confidence interval (CI), 10.7-14.0) versus 6.7 months (95% CI, 5.8-7.7) for chemotherapy, with a hazard ratio of 0.48 (95% CI, 0.38-0.59; p<0.0001). Trodelvy also demonstrated a statistically significant improvement in ORR (35%) and CBR (45%) compared to chemotherapy (5% and 9%, respectively). Ten complete responses were observed (4%) in the Trodelvy arm compared with two (1%) in the control group. As of data cutoff on
“We believe these remarkable results should facilitate the establishment of Trodelvy as a new standard of care in patients with third-line mTNBC,” said Dr.
Trodelvy was well tolerated by patients in the ASCENT study, with a manageable safety profile consistent with the
“We are delighted to witness the clinically meaningful survival benefit Trodelvy is bringing to mTNBC patients. These outstanding results have inspired us to fully demonstrate the potential of this valuable new treatment to improve the outlook of cancer patients worldwide,” commented Dr.
Trodelvy was approved as a third-line treatment for adult patients with mTNBC under the FDA’s Accelerated Approval Program and carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1
The Company will host a conference call and live audio webcast with key opinion leaders today at
About Triple-Negative Breast Cancer (TNBC)
TNBC is an aggressive type of breast cancer, accounting for up to 20 percent of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is highly prevalent in
The international, open-label confirmatory Phase 3 study enrolled more than 500 patients with metastatic triple-negative breast cancer who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either Trodelvy or a physician’s choice of chemotherapy. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response, time to onset of response, and other measures of safety and tolerability. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.
Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers. Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells.
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This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding expectations for achieving full FDA approval based on our confirmatory data for TRODELVY and the Company’s development of TRODELVY for additional indications, clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s reliance on third-party relationships and outsourcing arrangements (for example in connection with manufacturing, logistics and distribution, and sales and marketing) over which it may not always have full control, including the failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational or commercial products and, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on our products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain or obtain full regulatory approval for the Company’s products, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the uncertainties inherent in research and development; safety and efficacy concerns related to the Company’s products and product candidates; uncertainties in the rate and degree of market acceptance of products and product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s products and product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s products and product candidates or limitations by regulators on the proposed treatment population for the Company’s products and product candidates; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the Company’s products and product candidates; the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations; new product development (including clinical trials outcome and regulatory requirements/actions); the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates; risks relating to the COVID-19 pandemic in the
1. TRODELVY Prescribing Information.
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