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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Neoadjuvant Nivolumab Appears Safe and Feasible in Lung Cancer

Excerpt:

“Neoadjuvant immunotherapy with the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) is safe and feasible in early-stage non–small cell lung cancer (NSCLC). The results come from the first report of PD-1 blockade prior to surgery in this tumor, according to Patrick Forde, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, who reported these findings at the 2016 European Society for Medical Oncology (ESMO) Congress.”

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Neoadjuvant Nivolumab Appears Safe and Feasible in Lung Cancer

Excerpt:

“Neoadjuvant immunotherapy with the programmed cell death protein 1 (PD-1) inhibitor nivolumab (Opdivo) is safe and feasible in early-stage non–small cell lung cancer (NSCLC). The results come from the first report of PD-1 blockade prior to surgery in this tumor, according to Patrick Forde, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, who reported these findings at the 2016 European Society for Medical Oncology (ESMO) Congress.

” ‘Thirty-nine percent of patients with early-stage NSCLC treated with two doses of nivolumab had major pathologic responses associated with immune cell infiltration of tumor,’ Dr. Forde reported. ‘One hypothesis is that having tumor in situ when you give anti–PD-1—having more antigen present—may be better than giving it in the adjuvant setting, where only micrometastases may be present.’ ”

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Nivolumab Combos Explored in First-Line NSCLC Trial

Excerpt:

“Although nivolumab (Opdivo) has demonstrated a clear survival advantage compared with chemotherapy in patients with progressive non–small cell lung cancer (NSCLC) who express PD-L1 in their tumor cells, the same cannot be said for those who are PD-L1–negative.

“As a result, researchers are seeking to elicit antitumor activity in a broader range of patients, notably through a multiarm trial evaluating the PD-1 inhibitor along with combinatorial approaches.

“CheckMate-227 (NCT02477826) is a phase III, open-label, randomized trial for patients with chemotherapy-naïve stage IV or recurrent NSCLC. The trial will enroll patients into separate groups according to PD-L1 expression status (≥1% or <1%).”

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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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