Treating 'Out-of-the-Box' Melanoma Patients With Anti-PD-1s

Excerpt:

“Clinical trials that led to the approval of new therapies often have strict exclusion criterion, and so yield no data on how the drugs fare in patients with preexisting conditions. For that, data from the real-world setting are needed, and the latest to come in for the anti-PD-1 immunotherapies are data to show that they are safe and effective even in patients with preexisting autoimmune diseases.

“Researchers reporting a retrospective study at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting say that the new data are reassuring and that preexisting autoimmune diseases should not preclude treatment with immunotherapy with the PD-1 inhibitors pembrolizumab (Keytruda, Merck & CO) and nivolumab (Opdivo, Bristol-Myers Squibb).”

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Osimertinib Demonstrates Early Efficacy for Leptomeningeal Disease in NSCLC

Excerpt:

“Phase I findings of a study examining the efficacy of osimertinib (Tagrisso) in heavily pretreated patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC) and leptomeningeal disease showed promising activity in the patient population.

“In the BLOOM study, which was presented during the 2016 ASCO Annual Meeting, treatment with the third-generation EGFR TKI osimertinib was associated with radiologic improvement of leptomeningeal disease in 33% and neurologic improvement in patients who presented with neurologic impairment at baseline. In addition, 2 of the 21 patients (9.5%) enrolled experienced clearing of cerebrospinal fluid (CSF) cytology, said James Chih-Hsin Yang, MD, PhD, who announced the results.”

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Can Liquid Biopsies and Tumor Biomarkers Personalize Prostate Cancer Treatment?

Excerpt:

“Experimental, minimally invasive ‘liquid biopsy’ blood tests might soon help to personalize prostate cancer treatment by predicting androgen resistance and survival benefits from particular treatments, researchers announced at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago.

“Liquid biopsies detect circulating tumor cells (CTCs) or bits of tumor DNA (ctDNA). Not all tumors shed cells or DNA into a patient’s bloodstreams, but most do. And when they do, they can reveal a lot about themselves—including molecular signatures that can be targeted with specific treatments.

“Recent years have seen an explosion of candidate biomarkers for prostate cancer and other malignancies, including both liquid biopsies and tumor-sample gene panels. Most candidate biomarkers have been prognostic gene-mutation signatures that can estimate patient survival regardless of what treatment strategies are attempted. These prognostic tests can be useful for risk-stratifying patients who are participating in clinical studies, or in communicating prognosis to a patient and his loved ones.”

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Brigatinib Shows Promise in ALK-Positive NSCLC After Crizotinib Therapy

Excerpt:

“The investigational tyrosine kinase inhibitor (TKI) brigatinib offered good response rates in a pivotal phase II trial of patients with ALK-positive non–small-cell lung cancer (NSCLC) whose disease progressed on crizotinib. The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago (abstract 9007).

“ ‘Most ALK-positive NSCLC patients treated with crizotinib eventually progress, often due to acquired ALK resistance mutations and/or poor CNS drug penetration,’ said Dong-Wan Kim, MD, PhD, of Seoul National University Hospital in South Korea, who presented the study.

“Brigatinib, a next-generation ALK TKI designed to have broad activity against resistant ALK mutants, showed promising clinical activity in a phase I/II study of crizotinib-treated ALK-positive NSCLC patients. The new open-label phase II ALTA study included 222 patients with locally advanced or metastatic NSCLC who had progressive disease on crizotinib. Patients were randomized to two brigatinib treatment regimens: group A (112 patients) received oral brigatinib 90 mg once per day, and group B (110 patients) received the same dose for 7 days followed by 180 mg once per day.”

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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3-Year Follow-Up Data for Dabrafenib/Trametinib Confirm Results of Combo in Melanoma

Excerpt:

“Three-year follow-up data from the phase III COMBI-d study was presented at the 2016 ASCO Annual Meeting, revealing impressive overall survival (OS) and progression-free survival (PFS) data for the dabrafenib (Tafinlar) and trametinib (Mekinist) combination therapy for patients with BRAF-mutant metastatic melanoma.

“At the February 15, 2016 data cutoff for the 3-year analysis, 58% of patients remained on therapy. The 3-year PFS rate with the combination was 22% versus 12% with single-agent dabrafenib. The 3-year OS rate was 44% with dabrafenib plus trametinib compared with 32% with dabrafenib alone.

” ‘This is the longest OS follow-up among randomized phase III trials evaluating a BRAF plus MEK inhibitor in patients with BRAF-mutant metastatic melanoma,’ said lead investigator Keith T. Flaherty, MD, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. ‘With additional follow-up, and now 3-year maturity, dabrafenib plus trametinib continued to show significant benefit over dabrafenib monotherapy, despite crossover.’ ”

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Combining BRAF Inhibition, Anti-PD-1 No Help in BRAF-Mutant Melanoma

Excerpt:

“Patients with BRAF-mutant melanoma obtained no survival benefit from combined treatment of anti-BRAF therapy and an immune checkpoint inhibitor, a retrospective analysis showed.

“Median progression-free survival (PFS) was 6.0 to 6.5 months in BRAF-inhibitor naive patients who received a PD-1/PD-L1 inhibitor alone or with a BRAF inhibitor. Patients with prior exposure to a BRAF inhibitor had a median PFS of 8.0 months with anti–PD-1 therapy and 4.5 months with combined treatment. Median overall survival was 10.5 to 12 months with a PD-1/PD-L1 inhibitor alone or in combination with a BRAF inhibitor, regardless of prior BRAF inhibitor exposure status.

“ ‘BRAF inhibitor-refractory patients derived no additional benefit with anti-PD therapy in combination with BRAF inhibition,’ Wen-Jen Hwu, MD, of MD Anderson Cancer Center in Houston, and colleagues concluded in a poster presentation at the 2016 ASCO Annual Meeting in Chicago. ‘Clinical findings are similar with either anti-PD alone or in combination with BRAF inhibition in terms of objective response rate (ORR), disease control rate (DCR), and overall survival (OS).’ ”

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Black Women Less Likely to Pursue BRCA Testing and Cancer Risk Reduction Measures

Excerpt:

“Findings from a population-based study reported at the 2016 ASCO Annual Meeting revealed that young black women with breast cancer are much less likely to undergo testing for the BRCA gene than other women. Or, if they do carry a BRCA mutation, they are less likely to get a prophylactic mastectomy or salpingo-oophorectomy to reduce the risk of developing cancer.

“The research identified disparities in recipients of BRCA testing between non-Hispanic white women, Hispanic, and black women, with the latter being the least likely to undergo testing. Likewise, black women who were BRCA carriers were less likely to undergo risk-management practices compared with their white and Hispanic counterparts.

“ ‘We need to understand the reasons for these findings,’ said lead study author Tuya Pal, MD, a clinical geneticist at the Moffitt Cancer Center in Tampa, Florida. Ultimately, it’s the patient who must decide whether to have genetic testing and take prophylactic measures for risk management, Pal said.”

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AbbVie Shares Fall on Low Survival Data for Lung Cancer Drug

Excerpt:

“AbbVie Inc.’s shares fell Monday after an early trial showed patients taking the company’s experimental lung cancer drug survived fewer months than typical of those on chemotherapy, raising questions as to whether the company was right to buy the medicine in a $5.8 billion deal.

“AbbVie’s drug is known as Rova-T. In patients with an aggressive form of lung cancer who expressed more of the protein marker known as DLL3 that’s targeted by the drug, median survival was 5.8 months, according to data presented Sunday at the annual meeting of the American Society for Clinical Oncology in Chicago. With the only approved drug for recurrent disease, a form of chemotherapy called topotecan, median overall survival is about seven months, according to Tony Butler, an analyst at Guggenheim Partners.

“Rova-T’s initial survival data could be a disappointment to investors, Barclays analyst Geoff Meacham said in a note to clients. AbbVie’s shares dropped 4 percent to $62.42 at 10:32 a.m. in New York.”

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