Nivolumab Combinations Feasible for Newly Diagnosed GBM

Excerpt:

“The PD-1 inhibitor nivolumab (Opdivo) was successfully combined with radiotherapy alone or concurrently with temozolomide for patients with newly-diagnosed glioblastoma multiforme (GBM) in cohorts 1c and 1d from the phase I CheckMate-143 study, according to findings presented at the 2016 Society for Neuro-Oncology Annual Meeting.

” ‘The research question was if treatment with nivolumab to block immune checkpoint pathways could potentiate an antitumor immune response and have synergistic effects with radiotherapy or chemoradiotherapy in patients with newly diagnosed GBM,’ stated first author by Antonio Omuro, MD, of the Memorial Sloan Kettering Cancer Center.”

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MRI Tied to More Aggressive Breast Cancer Treatment

“The use of preoperative magnetic resonance imaging (pMRI) in women with newly diagnosed breast cancer has increased by eightfold during the past 10 years in Canada’s most populous province and is associated with significant increases in adverse downstream consequences, including more mastectomies, a population-based study indicates.

“The research was published online September 24 in JAMA Oncology.

“Angel Arnaout, MD, University of Ottawa, in Ontario, and colleagues found that 14.8% of a cohort of 53,015 women treated with newly diagnosed breast cancer between 2003 and 2012 had undergone pMRI in the province of Ontario.

“A total of 65% of the cohort underwent breast-conserving surgery.”


Study Supports Early Intervention for Prostate Cancer Patients Who Experience Significant Emotional Distress

“A study led by the University at Buffalo and Roswell Park Cancer Institute has identified beliefs and personality traits that are associated with higher levels of distress in newly diagnosed prostate cancer patients.

“The findings support the value of emotional and informational support for patients and perhaps early counseling for some who are the most distressed.

“Factors that were associated with greater distress included a lack of confidence in deciding how to treat the cancer, being concerned that the cancer will progress, feeling that one’s masculinity was under threat and tendencies to be less optimistic and resilient.

“The study, ‘Factors Associated with Emotional Distress in Newly Diagnosed Prostate Cancer Patients,’ was first published online in Psycho-Oncology in January 2015. The results are from a larger longitudinal study of prostate cancer patients, ‘Live Well Live Long!’ The research was based on assessments of 1,425 men newly diagnosed with prostate cancer at five different centers.”


New Positive Data Emerge on Palbociclib, a Drug Recently Approved for ER+ Breast Cancer

“Palbociclib, an investigational oral medication that works by blocking molecules responsible for cancer cell growth, is well tolerated and extends progression-free survival (PFS) in newly diagnosed, advanced breast cancer patients, including those whose disease has stopped responding to traditional endocrine treatments. Results of the phase II study, led by researchers in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania , were published this month in Clinical Cancer Research. Earlier phase I results by researchers at Penn Medicine contributed to the development of palbociclib, which was recently approved by the U.S. Food and Drug Administration (FDA) for metastatic breast cancer patients just beginning to undergo endocrine therapy.

” ‘The FDA approval has expanded treatments options for many metastatic breast cancer patients, but these new results are showing how effective the drug can also be for breast cancer patients who have already tried endocrine therapies and may be running out of options,’ said lead investigator Angela DeMichele, MD, MSCE , associate professor in the division of Hematology/Oncology and Epidemiology and co-leader of the Breast Cancer Research Program at the Abramson Cancer Center. ‘Combined with the promising results from other trials looking at the effectiveness of this drug, our results indicate that palbociclib can extend the duration of disease control and produce tumor shrinkage in patients with estrogen-receptor positive (ER+) breast cancer, without the debilitating side effects of chemotherapy.’ “


Plexxikon and QuantumLeap Healthcare Collaborative Announce Selection of PLX3397 for I-SPY 2 TRIAL in Breast Cancer

The gist: A new drug called PLX3397 will now be available through the innovative I-SPY 2 clinical trial, which uses molecular testing to match breast cancer patients to the pre-surgery treatments most likely to work for them. The trial is open for participation by women with newly diagnosed, locally advanced breast cancer.

“Plexxikon Inc., a member of Daiichi Sankyo Group, and QuantumLeap Healthcare Collaborative today announced that Plexxikon’s drug candidate, PLX3397, has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (minimum of Stage 2) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery).

“I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The trial is sponsored by QuantumLeap Healthcare Collaborative (QLHC), a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions.

“The I-SPY 2 TRIAL employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (‘biomarkers’) from individual patients’ tumors are used to screen promising new treatments, identifying which therapies are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may ‘graduate’ from I-SPY. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.”


Synta Announces Advancement of Ganetespib into Phase 3 Extension of AML LI-1 Study for Patients with AML and High-Risk MDS

The gist: Researchers are conducting a clinical trial with volunteer patients to test new treatments for newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who, for whatever reason, cannot undergo intensive chemotherapy. One of the treatments being tested combines the drugs ganetespib and cytarabine. Based on promising results for patients from phase 2 of the trial, the combination treatment is advancing to phase 3, in which it will be tested in even more patients.

“Synta Pharmaceuticals Corp. SNTA +2.46% today announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 (less intensive) trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine (Ara-C), in newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who are not eligible for intensive chemotherapy. Ganetespib is a next-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 1000 patients to date.

“Advancement into the Phase 3 extension follows an interim analysis of results from 50 patients who received the ganetespib-cytarabine combination in the Phase 2 portion of the trial. The primary efficacy outcome in Phase 2 was rate of complete response. Per protocol, the Phase 3 extension will include an interim futility analysis and enroll approximately 200 patients in the ganetespib-cytarabine and the cytarabine alone arms, for a total of approximately 400 patients. The primary efficacy endpoint for the Phase 3 extension will include overall survival. The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized.”


Agenus Brain Cancer Vaccine Nearly Doubles Survival Rate in Study

“Agenus Inc said its experimental cancer vaccine helped brain tumor patients live nearly twice as long compared with those who received standard of care treatment…

“The drug, when given in addition to standard treatment, extended median overall survival in 50 percent of newly-diagnosed glioblastoma multiforme (GBM) patients to two years in a mid-stage study.

“GBM patients, who tend to succumb to the disease within one year, are usually treated with a combination of radiation and the chemotherapy drug temozolomide.”

Editor’s note: Prophage is a new “cancer vaccine” that might boost a patient’s own immune system to help fight cancer. Cells from each patient’s tumor are used to personalize Prophage specifically for the patient. This article discusses results from a clinical trial testing Prophage in volunteer patients with glioblastoma multiforme (GBM). Some of the patients in the trial were treated with Prophage in combination with standard radiation and chemotherapy treatment, while for comparison, others were treated only with standard radiation and chemo. The results showed that adding Prophage to standard treatment can help some patients live longer.


Faster Genetic Testing Method will Likely Transform Care for Many Patients with Breast Cancer

“When a woman is diagnosed with breast cancer, it’s important to know as much about her tumour as possible to determine the best treatment. Most cases of breast cancer are sporadic, but a minority are hereditary and caused by one or more mutations in genes such as BRCA1 or BRCA2. To find such genetic mutations in newly diagnosed patients, researchers must sequence the woman’s DNA, which is generally a relatively slow process that generates results weeks or months after patients have started treatment. Next generation sequencing (NGS) is a newer method of sequencing DNA that processes large amounts of data. It’s faster and more expensive than conventional sequencing, but in recent years it has become cheaper and more widely accessible by rapid advances in computing power. With the use of NGS, which will soon become the mainstay of clinical genetics, breast cancer units will likely be able to get the results of genetic testing before patients begin their breast cancer treatment.”