“Yesterday’s historic FDA approval of the first engineered T-cell treatment for cancer, Novartis’ Kymriah (tisagenlecleucel), was accompanied by inevitable questions about how the product would be priced. In the end, Novartis set the price at $475,000, which was lower than many analysts had predicted, considering the treatment is designed to cure some forms of acute lymphoblastic leukemia (ALL)—and in clinical trials it did just that for most patients.”
“The phase 3 study ACT IV showed that rindopepimut, an investigational vaccine against EGFRvIII, did not improve outcomes when added onto temozolomide (Temodar, Merck), the current standard of care. The combination of rindopepimut plus temozolomide provided a median survival of 20.0 months compared with 20.1 months for temozolomide alone in patients with newly diagnosed EGFRvIII glioblastoma and minimal residual disease (MRD) after surgical resection and adjuvant chemoradiation.
“The announcement that the trial results were negative was made some time ago, but full details of those results were published online August 22 in Lancet Oncology.”
“Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by van den Bent et al.
“In the open-label 2 x 2 factorial trial, 745 adult patients with newly diagnosed disease were randomized 1:1:1:1 between December 2007 and September 2015 to receive radiotherapy (59.4 Gy in 33 fractions of 1.8 Gy) alone (n = 187) or with (n = 185) adjuvant temozolomide (12 4-week cycles of 150–200 mg/m² given on days 1–5) or to receive radiotherapy with concurrent temozolomide at 75 mg/m²/d with (n = 188) or without (n = 185) adjuvant temozolomide.”
“With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research.
“There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on.
“The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients.”
“A University of Portsmouth academic has helped to develop European guidelines to treat brain tumours more effectively.
“Geoff Pilkington, Professor of Cellular and Molecular Neuro-oncology and one of the UK’s leading brain tumour specialists, was one of only three UK academics who devised the European Association for Neuro-Oncology (EANO) guidelines on the diagnosis and treatment of adult patients with astrocytic and oligodendroglial gliomas, including glioblastomas.”
“Patients who choose to receive alternative therapy as treatment for curable cancers instead of conventional cancer treatment have a higher risk of death, according to researchers from the Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center at Yale School of Medicine and Yale Cancer Center. The findings were reported online by the Journal of the National Cancer Institute.
“There is increasing interest by patients and families in pursuing alternative medicine as opposed to conventional cancer treatment. This trend has created a difficult situation for patients and providers. Although it is widely believed that conventional cancer treatment will provide the greatest chance at cure, there is limited research evaluating the effectiveness of alternative medicine for cancer.”
“The U.S. Food and Drug Administration has awarded orphan drug status to a promising immunotherapy vaccine developed at Roswell Park Cancer Institute. The FDA notified MimiVax LLC, a Roswell Park spinoff company, on Aug. 3 that its application for orphan status for SurVaxM as treatment for glioblastoma, a type of brain cancer, had been approved.
“Orphan status is a special designation awarded to encourage innovation and exploration of approaches to treat rare diseases that affect relatively few people. SurVaxM, also known as DRU-2017-5947, is an immunotherapy drug that targets survivin, a cell-survival protein present in most cancers.”
“When approved therapies don’t work, or stop working, for people with serious or life-threatening illnesses, it puts them in a difficult position. Some turn to clinical trials that are testing experimental treatments. But many can’t do that because they are too sick, don’t meet the requirements of the trial, or can’t afford to travel to the site of a trial. That doesn’t mean they are out of options.”