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Survival Effect of pCR Elusive in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Charles Bankhead, Senior Editor From: medpagetoday.com 80% lower risk of recurrence with surrogate endpoint, but link to survival unproven Neoadjuvant therapy that resulted in pathologic complete response (pCR) reduced the risk of breast cancer recurrence by 80%, pooled data from a phase II clinical trial platform showed. The results held up across all breast cancer subtypes and treatment regimens, …

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Myeloma Drug Gets All Thumbs Up From FDA Panel

In Clinical Studies News by Barbara Jacoby

By: Charles Bankhead From: medpagetoday.com An FDA advisory committee voted unanimously to recommend approval of the antibody-drug conjugate (ADC) belantamab mafodotin for last-line treatment of relapsed/refractory multiple myeloma (RRMM). In voting 12-0 in favor of approval, the Oncologic Drugs Advisory Committee (ODAC) found that belantamab mafodotin’s efficacy clearly outweighed the risk of a novel ocular toxicity not seen with other …

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Eli Lilly, Sermonix Pharma Partner on Phase II Trial of Drug Combo in Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com Columbus, Ohio-based Sermonix Pharmaceuticals said on Wednesday that it is collaborating with Eli Lilly in an upcoming Phase II trial studying Sermonix’s lasofoxifene in combination with Lilly’s CDK 4 and 6 inhibitor abemaciclib (Verzenio) in estrogen receptor-positive, HER2-negative metastatic breast cancer patients who also harbor an ESR1 mutation. The trial, which is expected to start …

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Endoxifen Uses Window-of-Opportunity to Reduce Tumor Activity in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Nichole Tucker From: targetedonc.com Administering endoxifen in the window of opportunity between diagnosis and treatment may be effective for reducing tumor activity in patients with breast cancer. In the opening between breast cancer diagnosis and surgery, endoxifen may be effective for reducing tumor cell proliferation, leading to Ki-67 change, according to interim analysis results from a phase II clinical …

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Chemotherapy-Free Drug Combination Shows PFS Benefit for Women With HER2-Positive Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Hopkins From: precisiononcologynews.com Results from the Phase II monarcHER study published last week in Lancet Oncology demonstrated that women with advanced HER2-positive breast cancer may benefit from a combination of three non-chemotherapy agents: the CDK4/CDK6 inhibitor abemaciclib (Lilly’s Verzenio), the HER2-targeted therapy trastuzumab (Genentech’s Herceptin), and the anti-estrogen therapy fulvestrant (AstraZeneca’s Faslodex). The study showed a significant improvement …

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FDA Approves Novartis’ Capmatinib, Foundation Medicine CDx for Metastatic NSCLC

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: genomeweb.com The US Food and Drug Administration on Wednesday approved capmatinib (Novartis’ Tabrecta) for treatment of patients with metastatic non-small cell lung cancer. The agency also approved Foundation Medicine’s FoundationOne CDx assay, a broad comprehensive genomic profiling test for solid tumors, as a companion diagnostic for the drug. A companion diagnostic for capmatinib with Foundation’s liquid …

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Immunomedics’ Trodelvy wins FDA nod for triple-negative breast cancer

In Clinical Studies News by Barbara Jacoby

By: Randy Osborne From: bioworld.com Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy …

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Trastuzumab Deruxtecan Approved in Japan for HER2+ Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved trastuzumab deruxtecan (Enhertu) for the treatment of patients with HER2-positive unresectable or recurrent breast cancer who have had prior chemotherapy and are refractory or intolerant to standard treatments. The approval is based on findings from the phase II DESTINY-Breast01 trial, in which the …

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John Theurer Cancer Center Launches Clinical Trial of Personalized Cancer Vaccine Using New Gene-Based Technology for High-Risk Melanoma

In Clinical Studies News by Barbara Jacoby

From: PR Newswire Researchers hope the vaccine, combined with immunotherapy, can reduce the risk of relapse in patients after melanoma surgery John Theurer Cancer Center at Hackensack University Medical Center is the only site in New Jersey and one of just 17 in the country participating in a multicenter international Phase II study of an innovative personalized cancer vaccine being …

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GSK gets expedited FDA review for multiple myeloma drug

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The company anticipates the FDA to rule on the drug, belantamab mafodotin, in the first half of this year. If approved, it would be the first therapy targeting the cell-surface protein BCMA to hit the market. Several other anti-BCMA drugs are also in development. A British drugmaker said it could become the first company on …