Advaxis Combination Trial with Merck Completes First Two Dose-Escalation Cohorts


Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck & Co., Inc. (MRK), today announced that they have completed the first two dose-escalation cohorts and launched the third dose-escalation cohort in their KEYNOTE-046 clinical trial. The Phase 1/2 study is evaluating the combination of ADXS-PSA (ADXS31-142) and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

“The KEYNOTE-046 trial is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.”

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Video: Dr. Barbara Burtness on the Psychology of Talking to Patients About Enrolling in Clinical Trials

“Barbara Burtness, MD, professor of Medicine (Medical Oncology), Clinical Research Program Leader, Head and Neck Cancers Program, co-director, Developmental Therapeutics Research Program, Yale Cancer Center, discusses the psychology of talking to patients about being involved in a clinical trial.

“Burtness says on average, medical professionals should take about 4 minutes or longer to properly explain the clinical trial to their patients, as well as leave ample time for questions at the end of the conversation. She adds that patients should understand what the differences are between conventional therapies and investigational therapies are.”

Click through to watch the video.

Super Patient: Janet Freeman-Daily Joins a Clinical Trial—and Beats the Odds on Lung Cancer

In March 2011, Janet Freeman-Daily was about to take a long family trip to China. She’d been coughing for a while, so she asked her doctor for an antibiotic as a precaution before leaving. Even so, she came back in May with a respiratory infection that wouldn’t go away.

Her doctor ordered an X-ray and then a CT scan. “Before I got home, they called and said they’d like to do a bronchoscopy,” Janet says. The scan revealed a 7-cm mass in her left lung, and biopsies showed it was non-small cell lung cancer (NSCLC) and that it had spread to several lymph nodes. Continue reading…

ASCO Calls for Cancer Trials to Include More Seniors

“In a position statement published online July 20 in the Journal of Clinical Oncology, the American Society of Clinical Oncology has called on the U.S. government and the cancer research community to broaden clinical trials to include older adults.

” ‘Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,’ Julie Vose, M.D., M.B.A., society president, said in a news release from the group. ‘As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients, resulting in improved outcomes and manageable toxicity,’ she explained.

“More than 60 percent of cancers in the United States occur in people aged 65 and older, the statement authors say, noting the number of seniors will increase in coming years. However, there is a lack of evidence about cancer treatments for the elderly because too few are included in clinical trials, and clinical trials designed specifically for seniors are rare.”

Trial Availability, Patient Eligibility Barriers to Enrollment onto Genomically Matched Trials

“Only a small percentage of patients with actionable gene alterations are eventually enrolled onto genotype-matched trials targeting these alterations, according to study results.

“With the influx of targeted molecular therapies for the treatment of cancer, genomic profiling and matching patients to targeted therapies are imperative, according to study background.

“ ‘However, implementation of genomically informed therapy requires not only access to genomic profiling, but also the availability of molecularly targeted therapies matched to the genomic testing results,’ Funda Meric-Bernstam, MD, chair of the department of investigational cancer therapeutics, at The University of Texas MD Anderson Cancer Center, and colleagues wrote. ‘Availability of clinical trials may not only differ from institution to institution, but may also differ between tumor types. Enrollment onto clinical trials is also limited by trial eligibility criteria, as well as availability of slots.’ ”

Low Enrollment in Genomically Matched Clinical Trials After Genomic Testing

“In an analysis reported in the Journal of Clinical Oncology, Meric-Bernstam and colleagues at The University of Texas MD Anderson Cancer Center found that a small minority of patients with potentially actionable genes identified in large-scale testing were enrolled onto clinical trials targeting the alterations.

“The study included 2,000 consecutive patients with advanced cancer who underwent testing in a genomic testing protocol. Standardized hotspot mutation analysis was performed using either an 11-gene (251 patients) or a 46- or 50-gene (1,749 patients) multiplex platform. A total of 35 genes were considered potentially actionable, given the potential to be targeted with approved or investigational therapies.

“In total, 789 patients (39%) had at least one mutation in potentially actionable genes. Of them, 83 (11%) were enrolled in genotype-matched trials targeting these alterations. Among 230 patients with PIK3CA/AKT1/PTEN/BRAF mutations who returned for therapy, 116 (50%) received a genotype-matched drug; of them, 40 (17%) were treated in a genotype-selected trial requiring a mutation for eligibility, 16 (7%) were treated in a genotype-relevant trial targeting a genomic alteration without biomarker selection, and 40 (17%) received a genotype-relevant drug off trial.”

Living With Cancer: Clinical Trials Looking for Patients

“President Obama’s initiative to advance personalized medicine depends on the sort of breakthroughs in cell biology that have produced cancer drugs like the one extending my life. Yet very few adults with cancer enroll in clinical trials. Why do many trials fail to enroll sufficient patients, when scientists now test less debilitating therapies than those commonly used?

“I entered a Phase I trial in August 2012. Recurrences had proved that standard treatments could not eradicate my ovarian cancer. The pills from my trial, which I take at home, have kept the cancer at bay for more than two years — without destroying my appetite, muddling my mind, or dampening my spirit the way three cycles of chemotherapy did when infused intravenously in the hospital. A reader informs me that for seven months this same drug gave him a “wonderful respite” from an aggressive prostate cancer.

“Instead of destroying all quick-growing cells as well as tumors, targeted drugs pinpoint cancer cells, enabling them to mature into normal cells or disabling them from reproducing. Researchers are using personalized medicine on virtually every type of malignancy with some success. A significant percentage of patients with leukemia have experienced a remission with the clinical drug AG-221, while the lives of a significant population of women with metastatic breast cancer have been extended by the drugs Kadcyla and Perjeta. Scientists in immunotherapy — which unleashes the immune system to kill cancer cells — have produced medicines that help people survive with metastatic melanoma and lung cancer.”

Super Patient: Patient Advocates Help Susan Steel Win Admittance to Clinical Trials

Update:  We are deeply saddened to report that Susan passed away on January 13, 2016. It is a privilege to continue to share her story and keep her memory alive.

When Susan Steel first noticed the mole that derailed her life ten years ago, she was busy raising two children and running two businesses. “I just wasn’t paying attention,” she says. It wasn’t until the mole grew and started to bleed that she finally saw a doctor—and then she was hit with the news that she had melanoma and that it had spread to her lymph nodes.

“My life changed very fast,” Susan recalls. “I was told that my chances were very slim and that I should get my affairs in order.” Continue reading…

Study Finds No Reason for Cancer Survivors to Be Excluded in Advanced Stage Lung Cancer Trials

“The common practice of excluding patients with a prior cancer diagnosis from lung cancer clinical trials may not be justified, according to a study by researchers from UT Southwestern Medical Center.

“Having previously had cancer did not impact clinical outcomes in advanced lung cancer patients and these patients therefore should be considered for inclusion in clinical trials seeking new therapies, according to the study, appearing in the Journal of the National Cancer Institute.

” ‘When it comes to clinical trial eligibility, a history of prior cancer should not count against you,’ said senior author Dr. David Gerber, Associate Professor of Internal Medicine in the Division of Hematology and Oncology in the Harold C. Simmons Comprehensive Cancer Center. ‘For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.’ “