FDA Approves Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer

Excerpt:

“On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

“Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.”

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The Link Between Apalutamide and QOL in Non-Metastatic CRPC

Excerpt:

“Adding apalutamide to androgen deprivation therapy (ADT) does not appear to harm health-related quality of life (HRQOL) in men with nonmetastatic castration-resistant prostate cancer (CRPC), according to new research published in Lancet Oncology.

“Previous research has showed that men in this patient population who received apalutamide had longer metastasis-free survival and a longer time to symptomatic progression compared with those who received placebo. This new study found that adding apalutamide still preserves HRQOL. Specifically, the group mean patient-reported outcome scores over time demonstrated HRQOL was maintained from baseline (initiation of apalutamide), and it was similar over time among men receiving apalutamide versus placebo.”

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Liquid Biopsy IDs More NSCLC Mutations, Yields Patient Therapy Response in Study of Guardant Test

Excerpt:

“New data this week has added evidence for the value of blood-based cancer testing in non-small cell lung cancer, demonstrating in a cohort of about 300 that comprehensive liquid biopsy — in this case Guardant Health’s Guardant360 test — can help identify targeted mutations in more patients than tissue sequencing.

“The study also found that patients treated on the basis of blood-based test results respond to treatment similarly to those treated based on tissue test results.”

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Groups Endorse Shorter RT for Prostate Cancer

Excerpt:

“Hypofractionated external beam radiation therapy (EBRT) for early prostate cancer represents a reasonable alternative to standard treatment protocols involving lower doses of radiation administered over a longer period of time, according to a new clinical guideline.

” ‘Moderately hypofractionated’ EBRT regimens result in similar disease control and side effects as compared with conventional protocols, although the shortened regimens confer a small risk of more short-term gastrointestinal toxicity. Additionally, physicians should counsel patients about the limited data on oncologic outcomes beyond 5 years of follow-up, according to a panel representing the American Society for Radiation Oncology, American Society of Clinical Oncology, and American Urological Association.”

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Immunotherapy Effective Against Hereditary Melanoma

Excerpt:

Individuals with an inherited form of skin cancer often have a poor prognosis. The type of immunotherapy that was awarded this year’s Nobel Prize in Physiology or Medicine is, however, particularly effective in this patient group, research from Karolinska Institutet in Sweden shows. The study is published in the Journal of Medical Genetics.

“Congenital mutations of the CDKN2A gene are the strongest known risk factors for inherited . Individuals with  who carry mutations in this gene also have , according to previous research.”

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Dual Neoadjuvant Checkpoint Blockade Feasible in Melanoma

Excerpt:

“Combination neoadjuvant immune checkpoint blockade therapy yielded promising outcomes in high-risk resectable melanoma, although toxicity was an issue, according to a phase II trial.

“The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) led to improved progression-free survival (PFS), distant metastasis-free survival (DMFS), and overall survival (OS) versus neoadjuvant nivolumab monotherapy in 23 patients with high-risk resectable melanoma, reported Jennifer A. Wargo, MD, of MD Anderson Cancer Center in Houston, and colleagues in Nature Medicine.”

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Biomarker Selects TNBC Patients for Targeted Therapy

Excerpt:

“A tumor necrosis-based gene expression signature (GS) successfully identified patients with triple-negative breast cancer (TNBC) responsive to neoadjuvant therapy with the novel targeted agent LCL161, according to researchers.

“The international, randomized phase II trial of 207 patients with localized TNBC showed that of the 30.1% with GS-positive disease, a significantly higher pathologic complete response (pCR) was seen in those treated with paclitaxel plus the inhibitor of apoptosis antagonist LCL161 compared with those treated with paclitaxel alone (38.2% versus 17.2%).”

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FDA Approves Vizimpro for EGFR-Mutated Non-Small Cell Lung Cancer

Excerpt:

“The FDA approved dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletion or exon 21 L858R substitution mutations.

“Dacomitinib (Vizimpro, Pfizer) is a once-daily oral pan-human EGFR tyrosine kinase inhibitor.”

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Pembrolizumab Plus Chemotherapy Prolongs OS, PFS for Metastatic Lung Cancer

Excerpt:

“The addition of pembrolizumab to chemotherapy extended OS and PFS compared with chemotherapy alone among patients with metastatic, squamous, non-small-cell lung cancer, according to results of the randomized phase 3 KEYNOTE-407 trial presented at International Association for the Study of Lung Cancer’s World Conference on Lung Cancer.

“The double-blind study included 559 treatment-naive patients with metastatic, squamous NSCLC. Patients who had symptomatic central nervous system metastases, a history of noninfectious pneumonitis that required the use of glucocorticoids, active autoimmune disease or who were receiving systemic immunosuppressive treatment were excluded.”

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