Inovio Pharmaceuticals Initiates Immuno-Oncology Clinical Study for Glioblastoma in Combination with Regeneron’s PD-1 Inhibitor

Excerpt:

“Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate cemiplimab (also known as REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals, Inc.(NASDAQ:REGN), in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.”

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Immune-Related Adverse Events Predict Efficacy of Nivolumab in NSCLC

Excerpt:

“While immunotherapy with programmed death receptor 1 (PD-1) inhibiting antibodies has revolutionized the treatment of non-small cell lung cancer (NSCLC), use of these agents comes at the cost of potential serious immune-related adverse events (irAEs). In melanoma, development of cutaneous irAEs, such as rash and vitiligo, during treatment with PD-1 inhibitors has been shown to be associated with survival benefit, suggesting that early onset of irAEs may predict treatment outcomes. However, in NSCLC, the predictive value of immunotherapy-related toxicity as a clinical marker for efficacy to PD-1 inhibition is unknown.  A multi-institution retrospective study investigated the relation between the development of irAEs and efficacy of PD-1 inhibitors in 134 patients with advanced or recurrent NSCLC who received second-line treatment with nivolumab. The primary outcome for this analysis was progression-free survival (PFS) according to the development of irAEs in a 6-week landmark analysis.”

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FDA Grants Priority Review to Opdivo for Resected, High-Risk Melanoma

Excerpt:

“The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.

“Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.”

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Nivolumab Benefits Patients With Melanoma Treated Beyond Progression

Excerpt:

“Patients with melanoma continued to experience tumor response to nivolumab monotherapy when treated beyond progression, according to a pooled analysis of data from the CheckMate 066 and CheckMate 067 studies.

” ‘The results of this analysis suggest that continued treatment with nivolumab [Opdivo, Bristol-Myers Squibb] may be an option to achieve further apparent clinical benefit in some patients with advanced melanoma,’ Georgina V. Long, PhD, BSc, MBBS, FRACP, chair of melanoma medical oncology and translational research at Melanoma Institute Australia and Royal North Shore Hospital of The University of Sydney in Sydney, Australia, and colleagues wrote.”

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Opdivo Fails to Demonstrate Survival Benefit in Phase 3 Brain Cancer Trial

Excerpt:

“Patients with glioblastoma multiforme, a type of brain cancer, who recurred following radiation therapy and Temodal (temozolomide), did not survive longer when treated with the PD-1 inhibitor Opdivo (nivolumab) compared to standard-of-care treatment with Avastin (bevacizumab).

The findings mean that the randomized CheckMate -143 Phase 3 trial (NCT02017717) has failed to meet its primary objective.

” ‘[Glioblastoma multiforme] is a historically difficult disease to treat and conventional treatment options have demonstrated limited responses,’ Fouad Namouni, MD, head of Oncology Development and head of Medical at Bristol-Myers Squibb, said in a news release. ‘We remain steadfast in our pursuit of treatments for diseases with the highest unmet need and continue our work to determine how our immuno-oncology agents can potentially improve outcomes for these patients.’ ”

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Immunotherapy Agents, Combinations to Compete for Frontline NSCLC

Excerpt:

“Immunotherapy agents, both as monotherapy and in combination, are emerging in the pipeline of non–small cell lung cancer (NSCLC) and could end up competing as frontline treatment for patients, explains Sukhmani Padda, MD.

“For example, the PD-1 inhibitor pembrolizumab (Keytruda) is the sole immunotherapy agent approved in the first-line setting for patients with NSCLC; however, many other immunotherapy agents and combination regimens are in development that are aimed at this line of therapy.”

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Pembrolizumab Affords Long-Term Survival to One-Fourth of Selected Patients With NSCLC, Alternative Statistical Model Suggests

Excerpt:

“Statistical modeling of long-term survival from the KEYNOTE trials of the programmed cell death protein 1 (PD-1)–inhibitor pembrolizumab ­(Keytruda) estimates that one-quarter of appropriately selected patients with advanced non–small cell lung cancer (NSCLC) may attain long-term survival.

” ‘In the context of the pembrolizumab program, these are the furthest-out data that we have so far, and I think they represent a remarkable step forward,’ commented Matthew D. Hellmann, MD, of Memorial Sloan Kettering Cancer Center, New York, who presented the analysis at the 2017 ASCO-SITC (Society for Immunotherapy of Cancer) Clinical Immuno-Oncology Symposium.”

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Super Patient: Peter Fortenbaugh Faces the Uncertainty of Pioneering Melanoma Treatment


In spring of 2014, Peter Fortenbaugh noticed what appeared to be a tick that had bitten his lower calf. “It turned out not to be a tick, but it didn’t really go away,” he says.

The spot began to grow and bulge, and in October, Peter showed it to his primary care doctor, who referred him to a dermatologist to remove it. At the time, Peter recalls, it did not occur to him that the growth could be serious.

“I was actually very concerned about skin cancer because I spent a lot of time out in the sun sailing,” Peter says. “I put on a tremendous amount of sunscreen and protection, but never on my legs…I never connected the dots.”

However, a biopsy of the growth came back positive for melanoma. Peter, who lives in Palo Alto, California, with his wife and three children, immediately reached out to several doctors in the San Francisco Bay Area, and all had the same advice: “Take it out, take a biopsy.” Continue reading…


Avelumab Shows Promise as Frontline Immunotherapy Alternative in NSCLC

Excerpt:

“Immunotherapy is quickly becoming a mainstay in the frontline setting for the treatment of patients with metastatic non–small cell lung cancer (NSCLC).

“In October 2016, the FDA approved the PD-1 inhibitor pembrolizumab (Keytruda) as a first-line treatment for patients with metastatic NSCLC whose tumors have at least 50% PD-L1 expression and who do not harbor EGFR or ALK mutations.”

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