For Now, Sequencing Cancer Tumors Holds More Promise Than Proof

Excerpt:

“People diagnosed with cancer understandably reach for the very best that medical science has to offer. That motivation is increasingly driving people to ask to have the DNA of their tumors sequenced. And while that’s useful for some malignancies, the hype of precision medicine for cancer is getting far ahead of the facts.

“It’s easy to understand why that’s the case. When you hear stories about the use of DNA sequencing to create individualized cancer treatment, chances are they are uplifting stories. Like that of Ben Stern.”

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US Awards Novartis’ Kisqali ‘Breakthrough’ Status

Excerpt:

“Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.

“The US Food and Drug Administration has awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.”

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Diffusion Pharmaceuticals Begins Phase 3 Clinical Trial with TSC in Glioblastoma Multiforme

Excerpt:

“Diffusion Pharmaceuticals Inc. DFFN, +2.38% (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced that a Phase 3 clinical trial using its lead small molecule trans sodium crocetinate (“TSC”) in patients with newly-diagnosed inoperable glioblastoma multiforme (“GBM”) brain cancer, is now open for enrollment. The trial, which has been named INTACT (INvestigating Tsc Against Cancerous Tumors), follows a previous Phase 2 GBM study in which the inoperable patient subgroup showed a nearly four-fold increase in survival compared with historical controls when TSC was added to their treatment regimen (40% alive at two years vs. 10.4%). TSC’s innovative mechanism of action affects the tumor micro-environment, making treatment-resistant cancer cells more susceptible to the tumor-killing power of conventional radiation therapy (“RT”) and chemotherapy (temozolomide) by re-oxygenation of the hypoxic portion of the tumor. The Company believes that a largely intact GBM tumor vasculature with limited surgical resection is conducive to TSC’s tumor re-oxygenation properties, and that this contributed to the survival increase in the Phase 2 GBM inoperable patient subgroup.”

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FDA Approves Stereotactic Radiotherapy System for Breast Cancer

Excerpt:

“The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study.

“In the small clinical trial, GammaPod was effectively used to deliver a single “boost” radiation dose of 8 Gy directly to the tumor, while only eliciting grade 1 adverse events (AEs). The system uses a vacuum-assisted breast cup guided by a CT simulator with 1 mm slice thickness to immobilize the breast, which ensures the accurate delivery of radiation to the tumor.”

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Apalutamide Granted FDA’s Priority Review for Nonmetastatic CRPC

Excerpt:

“Based on data from the phase III SPARTAN trial (ARN-509-003), apalutamide (ARN-509) has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

“The trial evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The primary endpoint of the study is metastasis-free survival.”

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Electric Fields Therapy Improved Survival for Glioblastoma

Excerpt:

“The addition of tumor-treating fields to maintenance temozolomide chemotherapy significantly delayed progression and improved overall survival in patients with glioblastoma who had received standard radiochemotherapy compared with maintenance temozolomide alone, according to final results of a trial published in JAMA.

“Tumor-treating fields use low-intensity, alternating electric fields delivered via transducer arrays applied to the scalp. Patients treated with combined tumor-treating fields and temozolomide had a 37% improvement in progression-free and overall survival.”

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Adjuvant Nivolumab Granted FDA Approval for Melanoma

Excerpt:

“Nivolumab (Opdivo) has received FDA approval for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease.

“The approval is based on findings of the randomized phase III CheckMate-238 trial, in which the recurrence-free survival (RFS) rate at 18 months with nivolumab was 66.4% (95% CI, 61.8%-70.6%) compared with 52.7% (95% CI, 47.8%-57.4%) for ipilimumab (Yervoy) in patients with stage IIIB/C or stage IV melanoma after surgery. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor (HR, 0.65; 95% CI, 0.53-0.80; P <.0001).”

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Pertuzumab and Other Agents Continue Progress in HER2+ Breast Cancer

Excerpt:

“The adjuvant treatment landscape for patients with HER2-positive breast cancer continues to grow, particularly following the recent FDA approval of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and chemotherapy, which was based on findings from the APHINITY trial.

“In the phase III trial, the combination demonstrated a 3-year invasive disease-free survival (DFS) rate of 94.1%, which represented an 18% reduction in the risk of developing invasive disease or death. The benefit was more pronounced among higher-risk patients. The DFS rate for patients with node-positive disease was 92.0% with pertuzumab versus 90.2% with standard therapy.”

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New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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