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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PD-1 Drug Exceeds Survival History in NSCLC

Excerpt:

“Long-term survival in non-small cell lung cancer (NSCLC) exceeded historical standards among patients treated with the immune checkpoint inhibitor nivolumab (Opdivo), according to a study reported here.

“The 129 patients in the study had an estimated 5-year overall survival of 16%. Among those with measurable levels of PD-L1 expression, 5-year survival ranged as high as 43%.”

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Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced that CheckMate -143, a randomized Phase 3 clinical trial evaluating the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme (GBM), did not meet its primary endpoint of improved overall survival over bevacizumab monotherapy. These data will be presented on May 7, 2017 at the World Federation of Neuro-Oncology Societies (WFNOS) meeting in Zurich, Switzerland.

” ‘GBM is a historically difficult disease to treat and conventional treatment options have demonstrated limited responses,’ said Fouad Namouni, M.D., head of Oncology Development and head of Medical, Bristol-Myers Squibb. ‘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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Five-year Survival Rate For Nivolumab-treated Advanced Lung Cancer Patients Much Higher Than Historical Rate

Excerpt:

“Treatment with the immune checkpoint inhibitor nivolumab (Opdivo) yielded durable responses in some patients with advanced non-small cell lung cancer (NSCLC), with a five-year survival rate of 16 percent, according to data from a phase I clincal trial presented here at the AACR Annual Meeting 2017, April 1-5.

“According to the National Cancer Institute’s SEER data, five-year survival rate for patients with advanced lung and bronchus cancer is 4.3 percent, and for those with advanced NSCLC, it is 4.9 percent.

” ‘This is the first report of the long-term survival rate in patients with metastatic NSCLC treated with an immune checkpoint inhibitor. Our study results show that for a small subset of patients, immunotherapy can work for a very long time,’ said Julie Brahmer, MD, associate professor of oncology at the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins.”

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Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced the first overall survival (OS) data from the Phase 3 CheckMate -067 clinical trial. With a minimum follow-up of 28 months, the median OS had not yet been reached in either of the two Opdivo treatment groups and was 20 months for the Yervoy monotherapy group (95% CI: 17.1-24.6). Opdivo in combination with Yervoy and as a monotherapy reduced the risk of death 45% [hazard ratio (HR) 0.55; 95% CI: 0.42-0.72; P<0.0001] and 37% (HR 0.63; 95% CI: 0.48-0.81; P<0.0001), respectively, compared with Yervoy alone. The two-year OS rates were 64% for the Opdivo plus Yervoy combination, 59% for Opdivo alone and 45% for Yervoy alone. Results will be presented today in the press program and an oral presentation during the Update, Novel Indication, and New Immuno-oncology Clinical Trials session from 3:35 to 3:50 p.m. ET (Late-Breaking Abstract CT075) at the American Association for Cancer Research Meeting 2017 in Washington, D.C.”

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Clinical Trials Test Treatments for High-Grade Brain Tumors


With a few exceptions, glioblastoma (GBM) remains largely incurable, and the U.S. Food and Drug Administration (FDA) has approved few treatments for the disease. Surgery (when feasible), radiation, and temozolomide are used in most patients. But even if a newly diagnosed tumor can be surgically excised, recurrences are too common.

In this blog post, I simply list some of the new treatments available in clinical trials for GBM and other high-grade brain tumors. Only drugs that have at least some preliminary results of activity are included, and the list is not meant to be fully comprehensive. The interested reader can judge for herself what might be of interest, keeping in mind that no single treatment is suitable or will work for all GBM patients. Continue reading…


FDA Grants Fast Track Designation to ImmunoPulse IL-12 for Melanoma

Excerpt:

“The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

“ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“ ‘With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,’ Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. ‘Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.’ ”

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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…


Concerns That Rosy Direct-To-Consumer Ads Hype Cancer Drugs To Vulnerable Patients

Excerpt:

“A few weeks ago, I was watching veg-out TV, quietly wondering to myself how a show called ‘Pure Genius’ could be so darned dumb.

“Then a commercial break added a new sort of mystification: A long, vivid ad touted the cancer drug Opdivo, a form of immunotherapy — an exciting new type of treatment that harnesses the body’s own immune system — for lung cancer.

“Lung cancer is the biggest cancer killer, so, in this anomalous country that allows direct-to-consumer drug ads, it was no surprise to see a lung cancer ad on network TV.”

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