Incyte Gains as Melanoma Combo Sees Success in Early-Stage Trial

Excerpt:

“Incyte Corp. rose to its highest level since January as one of its experimental drug yielded positive results in an early-stage trial when used in combination therapy for a form of skin cancer.

“About 74 percent of patients with advanced melanoma who received Incyte’s epacadostat in combination with Merck & Co.’s Keytruda saw their disease stabilize or improve, and the treatment was well tolerated. The shares gained 4.6 percent to $93.65 at 12:40 p.m. in New York, after earlier reaching $95.39.”

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Combining Cytokine-based Immunotherapy AM0010 with Pembrolizumab Yielded Durable Responses in Patients with Advanced Solid Tumors

Excerpt:

“A combination of the immunotherapies AM0010 and the immune checkpoint inhibitor pembrolizumab was well tolerated and resulted in durable objective tumor responses in some patients with renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC), according to data from a phase Ib clinical trial presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held Sept. 25–28.”

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Rizvi Recounts Recent Immunotherapy Advances in Lung Cancer

Excerpt:

“With frontline pembrolizumab (Keytruda) recently receiving a priority review, immune checkpoint therapy has moved 1 step closer to regulatory approval as a first-line treatment for non–small cell lung cancer (NSCLC).

“The review is based on data from from the phase III KEYNOTE-024 trial, in which frontline pembrolizumab improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with NSCLC and PD-L1 expression levels ≥50%.”

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Keytruda Receives FDA Breakthrough Therapy Designation, Priority Review for First-Line NSCLC

Excerpt:

“The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.

“The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.

“All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.”

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Is Keytruda Better than Opdivo?

Excerpt:

“Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

“The yet-to-be-published studies involve drugs in a new class designed to enable the body’s immune system to fight cancer.

“A recent trial of Merck’s Keytruda (pembrolizumab) showed that it worked better than chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in patients with high levels of the PDL1 protein, believed to help identify those most likely to benefit from this type of immunotherapy.”

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Incidence of PD-1 Inhibitor–Related Pneumonitis Highest in NSCLC, Renal Cell Carcinoma

Excerpt:

“PD-1 inhibitor–related pneumonitis occurred most frequently among patients with non–small cell lung cancer or renal cell carcinoma, according to results of a meta-analysis.

“The incidence of this adverse event also appeared greater during treatment with combination therapy.

“PD-1 inhibitors — including FDA–approved nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck) — are associated with unique toxicities known as immune-related adverse events. Pneumonitis is one such adverse event that, although rare, can be serious and life threatening.”

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Melanoma: New Drugs and New Challenges (Part 1 of 2)


New targeted and immunotherapy drugs have changed the diagnosis of metastatic melanoma from a death sentence into a disease that can potentially be managed and even cured. Nevertheless, these new drugs do not work in all patients, or they may stop working after a transient response. This post (part one of two) will describe ongoing efforts to find drug combinations with higher efficacy than single drugs and decipher the mechanisms underlying drug resistance. Continue reading…


Melanoma Tx Tied to Neurologic Disorder

Excerpt:

“Researchers reported two cases of demyelinating polyradiculoneuropathy after treatment with pembrolizumab (Keytruda) for advanced melanoma.

“The report, in a letter published Wednesday in the New England Journal of Medicine, raises concerns about serious, perhaps irreversible, and previously unknown adverse effects from this class of drug, which targets the PD-1 immune checkpoint pathway. These immunotherapies, offering a whole new way of attacking cancer, have generated excitement across the oncology community in recent years.

“The first patient was receiving treatment for recurrent nasal-cavity melanoma, and developed symptoms consistent with Guillain-Barré syndrome 8 weeks after beginning pembrolizumab therapy (2 mg/kg every 3 weeks), according to Philippe Saiag, MD, PhD, of Versailles Saint-Quentin-en-Yvelines University in Versailles, France, and colleagues.”

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Immunotherapy/Chemo Combinations Show Potential in NSCLC

Excerpt:

“Pembrolizumab (Keytruda) and nivolumab (Opdivo) have both made a significant difference for a high number of patients with advanced non–small cell lung cancer (NSCLC). However, there is still a great deal to learn about the optimal use of PD-1 inhibitors in the disease, says Shirish Gadgeel, MD.

“ ‘Both pembrolizumab and nivolumab are approved for the management of NSCLC and have shown activity,’ says Gadgeel, medical oncologist, leader of the Thoracic Oncology Multidisciplinary Team at Karmanos Cancer Center, Wayne State University. ‘When these agents do work, the benefit is for a prolonged period of time. However, these agents are only efficacious in a minority of patients—probably in the range of 20%.’ ”

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