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Keytruda Plus Chemo Shows High Response Rate in Triple-Negative Breast Cancer

In Clinical Trials by Barbara Jacoby

From: specialtypharmacytimes.com Pembrolizumab (Keytruda, Merck) plus chemotherapy demonstrated a statistically significant improvement in pathological complete response rate (pCR) as a neoadjuvant therapy in patients with triple-negative breast cancer (TNBC), according to new data from a phase 3 study. Approximately 15% to 20% of patients with breast cancer are diagnosed with TNBC, which can be more difficult to treat than other …

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Merck Data Are Another Step for Immunotherapy in Breast Cancer

In Clinical Trials by Barbara Jacoby

From: xconomy.com Merck this morning announced that a combination of its drug pembrolizumab (Keytruda) and chemotherapy succeeded in a Phase 3 study in breast cancer, a potentially notable advance for immunotherapy in treating the disease. Merck (NYSE: MRK) said that Keytruda and chemotherapy beat chemo alone when given to patients with triple-negative breast cancer in a study called Keynote-522. The …

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Olaparib Delays Progression in BRCA-Mutated Pancreatic Cancer

In Clinical Trials by Barbara Jacoby

By: Liam Davenport From: medscape.com Patients with metastatic pancreatic cancer who carry a BRCA gene mutation could see their disease progression slowed or even halted with olaparib (Lynparza, AstraZeneca), suggest the results from the phase 3 Pancreas Cancer Olaparib Ongoing (POLO) trial. Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes that is already approved for use in ovarian …

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MacroGenics Announces Positive Results from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

Study meets first sequential primary endpoint of progression-free survival (PFS) in head-to-head with current standard of care (trastuzumab and chemotherapy) MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced additional details of the results from the Phase 3 SOPHIA study of margetuximab in patients with …

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Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: yahoo.com Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor in gBRCA-mutated advanced breast cancer Pfizer Inc. (PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase …

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CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: apnews.com CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the …

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Approval decision delay seen as positive for Karyopharm

In Clinical Trials by Barbara Jacoby

By: Andrew Dunn From: biopharmadive.com Dive Brief: The Food and Drug Administration pushed back the deadline for an approval decision by three months for Karyopharm Therapeutics’ experimental cancer drug — and investors celebrated the delay. The drugmaker gave the agency additional clinical information on selinexor’s accelerated approval application as a late-line treatment for relapsed refractory multiple myeloma, leading the FDA …

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Intraoperative radiotherapy viable for certain patients with breast cancer

In Clinical Trials by Barbara Jacoby

By: Jennifer Southall From: healio.com Intraoperative radiotherapy remains a viable option for patients with low-risk breast cancer, according to a presenter at Miami Breast Cancer Conference. “Intraoperative radiotherapy has been used for at least 10 to 15 years and, in appropriately selected patients, published results of the treatment are quite good,” Frank A. Vicini, MD, FACR, FABS, FASTRO, radiation oncologist …

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Lilly’s CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Global, randomized, placebo-controlled study confirms CYRAMZA, in combination with erlotinib, significantly delayed disease progression in previously untreated patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations Global regulatory submissions to be initiated this year  Second positive Phase 3 study of CYRAMZA in metastatic non-small cell lung cancer Eli Lilly and Company (NYSE: LLY) today …

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Inovio Pharma (INO) Commences REVEAL 2 Global Phase 3 Clinical Study for the Treatment of HPV-Related Cervical Pre-cancer

In Clinical Trials by Barbara Jacoby

From: streetinsider.com Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced the initiation and opening of sites to enroll the second portion of the company’s Phase 3 program for VGX-3100, Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV). The study, named REVEAL 2, is the company’s confirmatory stage Phase 3 clinical study and is designed to evaluate the …