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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Bristol-Myers' Opdivo Fails Lung Cancer Trial; Shares Plunge

Excerpt:

“Bristol-Myers Squibb Co said its blockbuster Opdivo immunotherapy failed to slow progression of symptoms in previously untreated patients with advanced lung cancer, a major setback expected to benefit Merck & Co’s rival medicine.

“Shares of Bristol-Myers fell almost 16 percent to $63.54 on Friday after the company announced failure of the late-stage trial. Shares of Merck gained 8.7 percent to $62.89.

” ‘This is the worst-case scenario’ for Opdivo and Bristol-Myers, Leerink analyst Seamus Fernandez said in a research note. ‘There appears to be no silver lining.’ ”

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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…


Novel Combination Study Planned for SCLC

Excerpt:

“A phase I/II study will explore the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) with the PD-1 inhibitor nivolumab (Opdivo) alone or in combination with the CTLA-4 inhibitor ipilimumab (Yervoy) for patients with relapsed extensive-stage small cell lung cancer (SCLC).

“AbbVie, the developer of rovalpituzumab tesirine, and Bristol-Myers Squibb, the company marketing nivolumab and ipilimumab announced the phase I/II study in a joint press release. As single-agents, rovalpituzumab tesirine and nivolumab have each demonstrated promising early findings for patients with SCLC. Additionally, nivolumab plus ipilimumab sparked promising response rates and overall survival (OS) findings. Data for the 3 agents were recently presented at the 2016 ASCO Annual Meeting.”

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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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Combination of Nivolumab and Ipilimumab Moves Forward in NSCLC

Excerpt:

“How best to combine new immunotherapies is a burning question in oncology. A new study in the CheckMate series suggests that nivolumab (Opdivo) and ipilimumab (Yervoy) can be safely and effectively combined as first-line treatment of advanced non–small cell lung cancer (NSCLC), but further study is needed. This combination is being studied in the phase III CheckMate 227 trial. For now, a platinum-containing doublet is still the standard of care.

“ ‘Nivolumab plus ipilimumab has promising efficacy in advanced NSCLC. The combination is well tolerated, with no treatment-related deaths. Overall response rates range from 39% to 47%, and median duration of response has not yet been reached,’ said lead author Matthew Hellmann, MD, of Memorial Sloan Kettering Cancer Center, New York.

“Both nivolumab and ipilimumab enhance T-cell antitumor activity. The combination of nivolumab plus ipilimumab has been approved for the treatment of melanoma by the U.S. Food and Drug Administration (FDA). Nivolumab monotherapy has been approved by the FDA for adults with locally advanced NSCLC progressing after platinum-doublet chemotherapy.”

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Video: The Ideal Patient Population for the Use of Nivolumab in Treatment of NSCLC

Excerpt:

“Hossein Borghaei, DO, chief, Thoracic Oncology, director, Lung Cancer Risk Assessment, associate professor in the Department of Hematology/Oncology, Fox Chase Cancer Center, discusses the ideal patient population that can potentially benefit from the use of nivolumab in the treatment of non–small cell lung cancer.”

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Beyond PD-1/CTLA-4: Immunotherapy Combos Explore New Ground

Excerpt:

“A variety of dual immunotherapy combination regimens are currently under exploration that could build upon the success seen with the addition of the CTLA-4 inhibitor ipilimumab (Yervoy) to PD-1 blockade with nivolumab (Opdi­vo) for the treatment of patients with advanced melanoma, explained Omid Hamid, MD.

” ‘On the heels of the ipilimumab/nivolumab combination having such a high response rate, we have been looking to find other standard combinations for advanced melanoma,’ says Hamid, chief of Translational Research and Immunotherapy, director of Melanoma Therapeutics, The Angeles Clinic. ‘That is not to say that ipilimumab/nivolumab is not a standard; it is a breakthrough in showing that we can combine these types of agents and have good outcomes; however, it makes a lot of sense to look at these other combinations.’ ”

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First-Line Nivolumab Could Be Good Option in Lung Cancer

Excerpt:

“Two parts of a phase I trial found that nivolumab could be a good first-line treatment option for patients with advanced non–small-cell lung cancer (NSCLC). In one part of the study, the immunotherapy agent yielded good safety results and durable responses as monotherapy, and in the other, nivolumab combined with platinum-based doublet chemotherapy had more toxicity but again good responses.

“Currently, platinum-based doublet chemotherapy (PT-DC) is the standard of care as a first-line therapy for NSCLC that is not driven by an EGFR or ALK mutation or rearrangement.

“ ‘Immune checkpoint inhibitors represent a distinct approach to treating malignancies, with durable antitumor activity and the potential for long-term survival demonstrated in multiple tumor types, including NSCLC,’ wrote Scott Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, and co-authors of the monotherapy study.”

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