FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC Bookmark

Excerpt from The ASCO Post:

“Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

“Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.”

Go to full article published by The ASCO Post on Aug 20, 2018.

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Bevacizumab and Temozolomide in First Recurrence of Glioma Without 1p/19q Codeletion Bookmark

Excerpt from The ASCO Post:

“In a phase II trial funded by the European Organisation for Research and Treatment of Cancer and reported in The Lancet Oncology, van den Bent et al found no evidence of a survival benefit with the addition of bevacizumab (Avastin) to temozolomide in patients with a first recurrence of World Health Organization grade II or III glioma without the 1p/19q codeletion.

“In the open-label trial, conducted at 32 European centers, 155 patients were randomized between February 2011 and July 2015 to receive either temozolomide at 150 to 200 mg/m² on days 1 to 5 every 4 weeks for a maximum of 12 cycles (n = 77) or the same temozolomide regimen plus bevacizumab at 10 mg/kg every 2 weeks until disease progression (n = 78). Previous chemotherapy must have been stopped at least 6 months before enrollment, and radiotherapy, at least 3 months before enrollment. Overall, 44% of patients in the combination group and 47% in the temozolomide group had grade III disease.”

Go to full article published by The ASCO Post on Aug 20, 2018.

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ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation Bookmark

Excerpt:

“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”

Go to full article published by The ASCO Post on Aug 9, 2018.

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CNS Activity of EGFR Tyrosine Kinase Inhibitor in T790M-Positive Advanced NSCLC Bookmark

Excerpt from The ASCO Post:

“In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta) in patients with advanced EGFR T790M-positive non–small cell lung cancer (NSCLC).

“In AURA3, 419 patients with disease progression on prior EGFR tyrosine kinase inhibitor treatment were randomized 2:1 to receive osimertinib at 80 mg once daily or platinum plus pemetrexed. The current subgroup analysis was conducted in patients with measurable or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review.”

Go to full article published by The ASCO Post on Aug 13, 2018.

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Small Benefit Seen in Adding Radiation to DCIS Plan for Breast Cancer Bookmark

Excerpt from AJMC:

“Patients with ductal carcinoma in situ (DCIS) are often treated with radiation after lumpectomy, although it has remained unclear whether this can reduce the risk of dying from this noninvasive form of breast cancer. A new study published Friday said that the combination of the 2 treatments was associated with a small benefit in reduced risk of breast cancer death compared with lumpectomy or mastectomy alone.”

Go to full article published by AJMC on Aug 10, 2018.

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Combo Tx No Help After PSA Progression in mCRPC Bookmark

Excerpt from MedPage Today:

“Adding abiraterone acetate (Zytiga) to enzalutamide (Xtandi) did not improve progression-free survival (PFS) after prostate-specific antigen (PSA) progression in men on enzalutamide monotherapy for chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), researchers found.

“In the randomized, double-blind PLATO trial, the median PFS in patients treated with enzalutamide plus abiraterone and prednisone was 5.7 months. By comparison, the PFS was 5.6 months in the control group treated with abiraterone and prednisone plus placebo (hazard ratio [HR] 0.83; P=0.22).”

Go to full article published by MedPage Today on July 28, 2018.

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Study Describes Design, Validation of Foundation Medicine’s Blood-Based TMB Test Bookmark

Excerpt from GenomeWeb:

“Researchers from Genentech, Foundation Medicine, UC Davis, and other medical centers, have published a report on the development and early validation of Foundation’s planned blood-based tumor mutational burden test.

“Appearing today in Nature Medicine, the study describes the development of the test and its characteristics, and its retrospective validation in two cohorts. Investigators demonstrated, by applying the assay to samples from two clinical trials, that blood-based TMB (bTMB) could reproducibly identify lung cancer patients who respond to immunotherapy treatment with Roche/Genentech’s atezolizumab (Tecentriq).”

Go to full article published by GenomeWeb on Aug 4, 2018 (Free registration required).

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Dana-Farber Researcher Sees Biomarker Potential in ESR1 Mutations Bookmark

Excerpt from OncLive:

“As a medical oncologist and investigator, Rinath M. Jeselsohn, MD, focuses on the detection and clinical implications of ESR1 mutations in estrogen receptor–positive breast cancer. She is a member of the research team in the lab of Myles A. Brown, MD, at Dana-Farber Cancer Institute in Boston, Massachusetts, where investigators are seeking to elucidate the factors underlying the mechanisms of hormone responsiveness, particularly steroid hormone receptors, in human cancers.

“Jeselsohn, who has led numerous studies into ESR1 mutations, discussed the field in an interview with OncologyLive^®.”

Go to full article published by OncLive on Aug 3, 2018.

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Brigatinib Confers Intracranial Responses in ALK-Positive Non-Small Cell Lung Cancer Bookmark

Excerpt from Healio:

“Brigatinib conferred substantial intracranial responses and durable PFS among patients with brain metastases and ALK-positive, non-small cell lung cancer previously treated with crizotinib, according to ongoing study results.

” ‘Crizotinib [Xalkori; Pfizer, EMD Serono], the first licensed ALK inhibitor, is very active but has clear central nervous system liability from poor CNS penetration. All of the next-generation ALK inhibitor drugs have started to show CNS efficacy consistent with their superior activity in the brain compared with crizotinib,’ D. Ross Camidge, MD, PhD, director of thoracic oncology at University of Colorado, told HemOnc Today. ‘The whole clinical trials field has had to evolve around these events in terms of how we should capture and present CNS data. Brigatinib [Alunbrig; Takeda Oncology, Ariad] was one of the drugs that helped with this.’ ”

Go to full article published by Healio on July 25, 2018.

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Atezolizumab Plus Chemotherapy Improves PFS for Triple-Negative Breast Cancer Bookmark

Excerpt from Healio:

“First-line atezolizumab plus nab-paclitaxel improved PFS compared with placebo among patients with metastatic or unresectable locally advanced triple-negative breast cancer, according to interim results from the IMpassion130 trial released by the manufacturer.

“Researchers observed prolonged PFS in both the intention-to-treat population and the PD-L1-positive population.”

Go to full article published by Healio on July 2, 2018.

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