World First as Viral Immunotherapy for Skin Cancer Shows Patient Benefit in Phase III Trial

“A genetically engineered herpes virus can halt the progression of skin cancer by killing cancer cells and sparking the immune system into action against tumours, a landmark clinical trial has shown.

“It is the first time that a phase III trial of viral immunotherapy has definitively shown benefit for patients with cancer.

“The trial was led in the UK by researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, and involved 64 research centres worldwide including the University of Oxford.

“Researchers randomised 436 patients with aggressive, inoperable malignant melanoma to receive either an injection of the viral therapy, called Talimogene Laherparepvec, or a control immunotherapy.”


Zapping Tumor Effective for Stage I Non-Small Cell Lung Cancer (CME/CE)

“Overall survival rates for resectable stage I non-small cell lung cancer (NSCLC) might improve if treated with stereotactic ablative radiotherapy (SABR) rather than lobectomy, the current standard of care, reports a phase III randomized U.S.-Dutch study led by researchers from the University of Texas MD Anderson Cancer Center in Houston.

“Furthermore, SABR is better tolerated.

“The findings, published in The Lancet Oncology, on May 14, 2015, are the first available data from randomized trials comparing SABR and invasive surgery with mediastinal lymph node dissection or sampling. Nonrandomized studies have previously suggested that SABR might be as effective as surgery, but these results are the first randomized data.

” ‘For the first time, we can say that the two therapies are at least equally effective, and that SABR appears to be better tolerated and might lead to better survival outcomes for these patients,’ said principal investigator Joe Y. Chang, MD, PhD, a professor of radiation oncology, in an MD Anderson media release. ‘This study can give physicians confidence to consider a noninvasive option.’ “


Docetaxel Improves Survival for Men with Hormone-Naive Prostate Cancer

“The addition of docetaxel to standard therapy clinically and significantly improved survival for men with locally advanced or metastatic hormone-naive prostate cancer, according to findings from the STAMPEDE trial.

“However, the addition of zoledronic acid to standard therapy was not associated with improved survival, results showed.

“ ‘We hope our findings will encourage doctors to offer docetaxel to men newly diagnosed with metastatic prostate cancer, if they are healthy enough for chemotherapy,’ Nicholas David James, MD, PhD, director of the cancer research unit at the University of Warwick and consultant in clinical oncology at Queen Elizabeth Hospital in the United Kingdom, said in a press release. ‘Men with locally advanced, nonmetastatic prostate cancer may also consider docetaxel as part of upfront therapy, as it clearly delays relapse.

“ ‘It’s also clear that zoledronic acid does not benefit these patients and should not be offered as an upfront treatment for advanced prostate cancer,’ James said.”


Breast Cancer Patients Over 60 with Luminal a Subtype May Not Need Radiation if Already on Hormone Therapy

“Women with luminal A subtype breast cancer – and particularly those older than 60 – may not need radiation treatment if they are already taking hormone therapy, shows clinical research led by radiation oncologists at the Princess Margaret Cancer Centre published online today in the Journal of Clinical Oncology.

“The findings potentially advance delivery of personalized cancer medicine for up to 25% of women diagnosed with breast cancer in North America every year, say co-principal investigators Dr. Fei-Fei Liu, Chief, Radiation Medicine, and Dr. Anthony Fyles, staff radiation oncologist. Dr. Liu is Chair, Department of Radiation Oncology, University of Toronto, where Dr. Fyles is also a Professor. In Ontario alone, they estimate, this could save the provincial health care system up to $3 million annually. Drs. Liu and Fyles talk about their research at https://www.youtube.com/watch?v=mrl5-1gsoSg .

“They stress, however: ‘For all other breast cancer subtypes, radiation therapy is definitely of benefit and the required treatment.’
Drs. Liu and Fyles examined tumour specimens from participants in a prior randomized clinical trial who received either tamoxifen (hormone therapy) plus whole-breast radiation therapy, or only tamoxifen.”


Generex Provides Data Update from AE37 Phase II Breast Cancer Trial One Year Post Completion of Enrollment

“Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) announced today that updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine under development at the Company’s wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).  The current analysis was performed on data that was examined one year after the last patient was enrolled into the trial.  The ASCO meeting will be held from May 29 to June 2, 2015 in Chicago, IL.

“The abstract, entitled ‘Final Pre-specified Analysis of the Phase II Trial of the AE37+GM-CSF Vaccine in High Risk Breast Cancer Patients to Prevent Recurrence”, by Julia Greene, et al will be presented on May 30 during the Breast Cancer – HER2/ER session.  The study reports on the anticipated five year disease free survival in patients enrolled in a controlled, randomized, and single-blinded Phase II trial that completed enrollment in January of 2014.  A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer.  This latter group represents a patient population of high unmet need.  The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.”


PharmaMar Announces New Advances in Oncology at ASCO 2015 for Its Compounds YONDELIS® and PM1183 in Small Cell Lung Cancer, Soft Tissue Sarcoma, and Mesothelioma

“PharmaMar announces that it will present several clinical studies to showcase the data obtained in various tumor types, including SCLC, soft tissue sarcoma and mesothelioma during the 51st American Society of Clinical Oncology meeting in Chicago (ASCO; May 29-June 2). Abstracts have been selected for oral presentation, poster discussion session and general poster presentation. The studies presented by the Company will include the first-in-class drug YONDELIS® (trabectedin), and the second-generation of this class, PM1183 (lurbinectedin). PM1183 is an inhibitor of the transcriptional machinery and a DNA repair complex, which have proven to be crucial in different tumor types, including SCLC, soft tissue sarcoma and ovarian cancer. In addition, these drugs have been shown to have an effect on the tumor microenvironment by targeting tumor-associated macrophages, which is relevant for cancers such as mesothelioma and ovarian cancer, in which chronic inflammation seems to be a hallmark of the disease.”


Stereotactic Ablative Radiotherapy Achieves Better Overall Survival than Surgery for Early Lung Cancer

“Patients with operable stage I non-small cell lung cancer (NSCLC) could achieve better overall survival rates if treated with Stereotactic Ablative Radiotherapy (SABR) rather than the current standard of care — invasive surgery — according to research from a phase III randomized international study from The University of Texas MD Anderson Cancer Center.

“The findings, published today in The Lancet Oncology, are from the first randomized clinical trials comparing SABR and surgery.

” ‘For the first time, we can say that the two therapies are at least equally effective, and that SABR appears to be better tolerated and might lead to better survival outcomes for these patients,’ said the first author and principal investigator Joe Y. Chang, M.D., Ph.D., professor, Radiation Oncology. ‘Stereotactic radiation treatment is a relatively new approach for operable early stage lung cancer, while surgery has been the standard for a century. This study can give physicians confidence to consider a non-invasive option.’ “


ASCO: Chemo-ADT Combo Still Winning in Prostate Cancer

“Men with advanced prostate cancer lived significantly longer if they received upfront chemotherapy in addition to androgen deprivation, results of a randomized trial showed.

“As compared with men who received only androgen deprivation therapy (ADT), those who also got docetaxel had a 10-month improvement in median overall survival (OS). The difference translated into a 24% reduction in the mortality hazard. Subgroup analysis showed that patients with metastatic disease at the start of treatment derived even greater benefit from docetaxel, a 22-month improvement in median overall survival.

“The study is at least the third reported within the past year showing a significant survival benefit with upfront docetaxel, making a strong case for standard of care, as reported during a press briefing prior to the American Society of Clinical Oncology meeting, which begins here May 29.

” ‘Our headline conclusion would be that docetaxel would be considered routine therapy for men with newly diagnosed metastatic disease,’ said Nicholas James, MD, of the University of Warwick and Queen Elizabeth Hospital in Birmingham, England.”


Roche: "Investigational Medicine Alectinib Shrank Tumours in Nearly Half of People with Specific Type of Lung Cancer"

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from two pivotal studies (NP28673 and NP28761) that showed alectinib, its oral investigational anaplastic lymphoma kinase inhibitor (ALKi), shrank tumours (overall response rate; ORR: 50% and 47.8%, respectively) in people with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. In addition, alectinib was shown to shrink tumours in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1% and 68.8%, respectively). Additionally, people whose tumours shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively (duration of response; DOR). Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common adverse events (Grade 3 or higher occurring in at least 2% of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea).1,2

“ ‘Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. ‘We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib.’ “