A Single Dose of a PD-1 Inhibitor Before Surgery May Predict Outcomes in Patients With Melanoma

Excerpt:

“A single dose of a programmed cell death protein 1 (PD-1) inhibitor before resection for melanoma may predict clinical outcomes for patients. Researchers from the Abramson Cancer Center at the University of Pennsylvania—who documented this finding in the largest cohort of patients to be treated with anti–PD-1 drugs before surgery—also showed that immune responses brought on by this therapy can peak as early as 7 days after treatment—much earlier than previous studies have shown. These findings were published by Huang et al in Nature Medicine.”

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What’s New in Melanoma Treatment in 2019?


It has been over a year since I last wrote about new developments in treatment of melanoma, and it is time for an update. There is certainly some good news for melanoma patients!

Neoadjuvant (before surgery) treatments for resectable melanoma

Stage III—and more rarely, stage IV—melanoma tumors that have not spread widely can be sometimes treated surgically. Last year a small clinical trial showed that, in BRAF-mutant melanoma, treatment with the BRAF/MEK inhibitors dabrafenib and trametinib (D/T) before and after surgery provides a significant improvement over just post-surgery treatment, by preventing later recurrence.

Later in 2018, researchers reported that using the immune checkpoint drugs nivolumab and ipilimumab prior to surgery led to tumor reduction in 73% of patients treated in a clinical trial. After surgery, they remained disease-free for 2 years (the reported time of observation). Treatment with nivolumab alone was not nearly as active in this randomized trial, with only 25% of patients responding to neoadjuvant nivolumab; still, 75% were disease-free within the 2-year observation period.

An interesting trial tested a single dose of the drug pembrolizumab given three weeks prior to surgery. Of 27 patients who received this single infusion, eight (29%) had a complete or major pathological response, meaning that their tumors were reduced by 90% or more. These eight patients continued on pembrolizumab after surgery and were disease-free for over 2 years. Continue reading…


Pembrolizumab Regimen Receives FDA Approval for Frontline Treatment of Squamous NSCLC

Excerpt:

“Based on findings from the phase III KEYNOTE-407 trial, pembrolizumab (Keytruda) has been approved by the FDA for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the frontline treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC).

“Results from the trial showed combining pembrolizumab with chemotherapy reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous NSCLC. The median overall survival (OS) was 15.9 months (95% CI, 13.2 – not evaluable) with pembrolizumab versus 11.3 months (95% CI, 9.5-14.8) with chemotherapy alone (HR, 0.64; 95% CI, 0.49-0.85; P = .0017). The OS benefit was observed regardless of PD-L1 expression level, choice of taxane, age, sex, and ECOG performance status.”

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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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Pembrolizumab Alone or With Chemotherapy for PD-L1–Positive NSCLC?

Excerpt:

“Researchers found that in patients with non–small-cell lung cancer (NSCLC) and a Tumor Proportion Score (TPS) ≥ 50, pembrolizumab plus chemotherapy failed to improve overall survival (OS) or progression-free survival (PFS) compared with pembrolizumab alone.

“Results from the study were presented in a poster presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer, held September 23–26 in Toronto.”

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Could Adding a TLR9 Agonist Improve Responses in Metastatic Melanoma?

Excerpt:

“A phase I trial found promising activity and good tolerability with the combination of pembrolizumab and a stimulant of Toll-like receptor 9 (TLR9) known as SD-101 in patients with unresectable or metastatic melanoma, particularly in those who had not received prior anti–programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) therapy.

“PD-1/PD-L1 inhibition has improved outcomes in metastatic melanoma, and studies have indicated that combination therapy can increase immune responses further. “Despite the improvement in response rates with combination immunotherapy, a large unmet need remains,” wrote study authors led by Antoni Ribas, MD, PhD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center.”

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

Excerpt:

“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.”

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FDA Grants Priority Review to Keytruda Plus Chemotherapy for Lung Cancer Subtype

Excerpt:

“The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.

“The agency set a target action date of Oct. 30.”

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FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC).

“This new approval of pembrolizumab was based on the results of the phase II KEYNOTE-021 clinical trial of 123 patients with advanced or metastatic nonsquamous NSCLC without mutations in the EGFR gene or alterations in the ALK gene, for which there are existing targeted therapies. Patients in the trial had not been treated previously and were randomly assigned to receive either pembrolizumab plus chemotherapy or chemotherapy alone.”

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