Updates to NSCLC Guidelines Make Testing at Diagnosis, Resistance Essential

Excerpt:

“Updates to the National Comprehensive Cancer Network (NCCN) guidelines for the management of advanced non–small cell lung cancer (NSCLC) stress the importance of multiplexed biomarker testing at diagnosis to aid in the selection of appropriate first-line and subsequent lines of therapy, said presenters at the 2017 NCCN Annual Conference.

“The latest version of the guidelines recommends that PD-L1, in addition to molecular analysis, be employed as a biomarker to direct initial therapy, with ≥50% expression established as the threshold for a positive result. The PD-L1 test ‘decides whether a patient has enough of the marker to warrant initial immunotherapy,’ said presenter Gregory J. Riely, MD, PhD.”

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FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC

Excerpt:

“On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

“In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib based on a blinded independent review committee (BIRC)-assessed overall response rate (ORR) of 44% among 163 patients in a single-arm trial.”

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Radiation Therapy Can Enhance Effectiveness of Immunotherapy in People With Advanced Lung Cancer, UCLA Study Finds

Excerpt:

“A new study by UCLA scientists has found that the breakthrough immunotherapy drug pembrolizumab can be more effective in improving survival in people with non-small cell lung cancer (NSCLC) if they have previously received radiation therapy, compared to those without a history of radiation treatment. The findings are important as the strategies of combining radiation therapy with anti-PD-1 antibodies such as pembrolizumb are currently being explored, and have the potential to increase the overall benefit of immunotherapy for people with NSCLC, the most common form of lung cancer.”

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First Clinical Trial of New Targeted Molecular Therapy in U.S. Takes Aim at Incurable Prostate Cancer

Excerpt:

“NewYork-Presbyterian and Weill Cornell Medicine have begun the first clinical trial in the United States that uses a small molecule to treat men with progressive prostate cancer that has spread beyond the prostate and is no longer responding to hormonal therapy. The Phase 1 study has completed its second round of patient enrollment, with the first six patients having undergone dosing. The researchers will be discussing the trial on June 5 at the 2017 American Society of Clinical Oncology meeting in Chicago.

“The researchers are using the small molecule Lutetium 177Lu-PSMA-617 to target prostate-specific membrane antigen (PSMA), a protein that is abundantly expressed in 85-90 percent of metastasized prostate cancers. The small molecule binds to PSMA and delivers precise radiation therapy intended to shrink the cancer — even in cases in which cells have yet to form a visible tumor on a bone or CT scan.”

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Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

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In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes

Excerpt:

“For the first time, the FDA has approved a drug for use in cancer—of any type—that harbors certain molecular features. Merck’s Keytruda, an immune oncology drug, may be prescribed for any resistant, metastatic tumor with microsatellite instability (MSI) or other evidence for defective DNA mismatch repair.

“This is good news for patients. Previously, Keytruda (pembrolizumab) was approved by the FDA for use in some forms of lung cancer, melanoma, head and neck cancer, and Hodgkin’s lymphoma. Now, patients can try this medication if they have advanced cancer of any form with pathological MSI or DNA mismatch repair defects. Microsatellite instability most often appears in colon cancers, affecting around 15% of cases. Variants of DNA mismatch repair genes are implicated in heritable cancer dispositions such as Lynch syndrome.”

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FDA Panel Backs Novel Anti-HER2 Drug for Breast Cancer

Excerpt:

“Another potential drug for HER2-positive breast cancer received strong numeric support from an FDA advisory committee, tempered by reservations about a broad indication, modest clinical benefit, and toxicity issues.

“By a 12-4 vote, the Oncologic Drugs Advisory Committee (ODAC) supported FDA approval of the dual HER2/EGFR inhibitor neratinib for early HER2-positive breast cancer that relapses after trastuzumab (Herceptin) maintenance therapy.”

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Expert Explains Individualized Decision on Endocrine Therapy Beyond 5 Years in Breast Cancer

Excerpt:

“Endocrine therapy remains an integral part of the treatment paradigm for patients with estrogen receptor (ER)–positive breast cancer; however, questions remain on which patients should continue their therapy beyond 5 years.

” ‘The idea [is] that most patients with hormone receptor (HR)-positive breast cancer who are still on endocrine therapy at 5 years are going to merit some sort of discussion about whether they should continue or not, and it is okay to individualize that decision on the basis of the patient preferences, side effects, and symptom burden,’ said Amye J. Tevaarwerk, MD.”

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Longer Survival Seen with Breast Cancer Mets

Excerpt:

“An increasing number of women in the U.S. survive with metastatic breast cancer (MBC) as both median and 5-year survival rates improved, especially among younger women, according to a back-calculation method study.

“As of Jan. 1, 2017, 154,794 women were estimated to be living with MBC in the country, 75% of whom had initial diagnoses of stage I to III breast cancer and later progressed to MBC, reported Angela Mariotto, PhD, of the NCI in Bethesda, Md., and colleagues.

“The data showed a twofold increase in 5-year survival for women, ages 15 to 49, with MBC at diagnosis (de novo MBC), from 18% in 1992-1994 to 36% in 2005-2012, they wrote in Cancer Epidemiology, Biomarkers & Prevention.”

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