CHICAGO – In a gigantic cancer meeting yielding few surprises, even the tiniest roil can send a biopharma into stormy seas. For Nektar Therapeutics Inc., the American Society of Clinical Oncology (ASCO) became the perfect storm for that scenario. Read More
CHICAGO – The last full day of the American Society of Clinical Oncology (ASCO) annual meeting included hopeful data regarding pancreatic tumors, long known as one of the more aggressive and intractable types. One dataset showed chemotherapy beat standard-of-care (SOC) Gemzar (gemcitabine, Eli Lilly and Co.), which has been favored for 10 years, and the other demonstrated that patients given chemo with radiotherapy before surgery conferred better disease-free survival than starting therapy with resection, the current SOC. Read More
CHICAGO – Taselisib (GDC-0032, RG-7604), the beta-isoform sparing phosphoinositide 3-kinase (PI3K) inhibitor previously advanced to no avail in non-small-cell lung cancer by Roche Holding AG unit Genentech Inc., showed only modest benefit in the phase III SANDPIPER study in individuals with estrogen receptor (ER)-positive, PIK3CA-mutant locally advanced (LA) or metastatic breast cancer (MBC). Read More
BOSTON – Following the Senate Health, Education, Labor and Pensions Committee's overwhelming approval to reauthorize the Pandemic and All Hazards Preparedness Act, which is set to expire in September, the House starts to examine renewal options for health emergency preparedness programs this week. It helps fund U.S. response to future threats and beef up the nation's medical countermeasure enterprise. But ultimately, some of the projects its funds flow to also support civilian biopharma ventures. Read More
CHICAGO – With a phase III success for moxetumomab pasudotox (moxe, formerly CAT-8015 or HA22) in the bag, Astrazeneca plc and its Medimmune unit aim to have the first drug approval in more than two decades to treat hairy cell leukemia (HCL). Read More
LONDON – Roche Holding AG has pulled the plug on its spinal muscular atrophy (SMA) drug, olesoxime (RG-6083), just as it was expected to start a phase III trial, blaming among other difficulties the higher hurdle set by Biogen Inc.'s Spinraza (nusinersen), for how effective a new treatment needs to be. Read More
CHICAGO – Speaking at the American Society of Clinical Oncology meeting, John Heymach of Houston's MD Anderson Cancer Center, called new phase III data with Merck & Co. Inc.'s Keytruda (pembrolizumab) "a double whammy" of upside for advanced non-small-cell lung cancer (NSCLC) patients: non-chemotherapy benefit with lower side effects. "An era in which chemotherapy was the only option for NSCLC patients has drawn to a close," he said. Read More
Despite opposition, the U.S. Department of Health and Human Services (HHS) is going ahead with its plan to delay implementing a 340B rule for another year. Read More
CHICAGO – Is precision medicine (PM) finally within sight? The long-heralded but largely overhyped model got a shot in the arm at the American Society of Clinical Oncology (ASCO) annual meeting in a retrospective analysis of consecutive, prospectively molecularly profiled patients with advanced cancer who participated in a large personalized medicine trial. Investigators found that using molecular tests of tumors to select targeted therapy resulted in slower cancer growth and prolonged survival across a diverse set of cancer types. Read More
CHICAGO – The word "race," when used in drug development, usually suggests a contest to reach the market first, but at the American Society of Clinical Oncology (ASCO) meeting, it became key topic of talk – more than once – in prostate cancer (PC) trials. Read More
CHICAGO – Research unveiled at the American Society of Clinical Oncology (ASCO) meeting equals what one specialist called "an absolutely practice-changing study" related to high microsatellite instability (MSI-H), a genomic marker associated with genetic mutations in tumors, and its relation to Lynch syndrome (LS), an autosomal dominant inherited condition known to increase the risk of developing some cancers. Read More
CHICAGO – Data from a randomized phase III trial showing that many people with renal cell carcinoma (RCC) can avoid surgery to remove the kidney "flipped the existing paradigm," said Sumanta Pal, medical oncologist with Duarte, Calif.-based City of Hope. "Even in the context of patients with advanced disease that has spread to the lungs, liver and other sites [cases account for about 20 percent of all worldwide], we've been removing the kidney, but admittedly this isn't based on a very high level of evidence until now," he said. Read More
CHICAGO – Phase III Impower131 findings with Tecentriq (atezolizumab, Roche Holding AG) when combined with chemotherapy in squamous-cell lung cancer, along with separate discoveries related to a would-be new blood test for early stage lung cancer emerged at the American Society of Clinical Oncology (ASCO) meeting. Read More
CHICAGO – "It's remarkable to me how the pediatric oncology community manages to continue to make great strides by using old drugs in new ways," American Society of Oncology (ASCO) Chief Medical Officer Richard Schilsky said during the group's meeting, as he spoke about the first advance in 30 years in rhabdomyosarcoma (RMS), a rare cancer of the muscle tissue that strikes children. Read More
CHICAGO – Rushed oncologists may feel they don't have time to talk through the concerns of older patients with them, and a systematic geriatric assessment (GA) could significantly change satisfaction all around, according to new research detailed at the American Society of Clinical Oncology (ASCO) meeting by lead study author Supriya Gupta Mohile, Wehrheim professor of medicine at the University of Rochester in New York. Read More
CHICAGO – The largest breast cancer adjuvant study ever performed, the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, showed conclusively that the Oncotype DX Breast Recurrence Score (RS) test identified 70 percent of early stage breast cancer patients who receive no benefit from chemotherapy and can be treated effectively with endocrine therapy (ET) alone. Findings also showed that chemotherapy may provide life-saving benefit to the other 30 percent of such patients. Read More
CHICAGO – One of the more eye-opening data rollouts at the American Society of Clinical Oncology (ASCO) involved an analysis of registry data from a California hospital system showing that women with head and neck cancer were, compared to men, less likely to receive intensive chemotherapy (35 percent vs. 46 percent) and radiation (60 percent vs. 70 percent) relative to men. But, controlling for age and other serious medical conditions, a mathematical model demonstrated that the ratio of cancer to noncancer mortality was two times higher for women than the ratio for men. Read More
A new report by the U.S. Health and Human Services Office of Inspector General (OIG) found that despite a 17 percent decrease in the number of prescriptions for brand drugs under Medicare Part D from 2011 to 2015, total Part D reimbursement for those drugs increased 77 percent. Read More
Denovo Biopharma LLC, of San Diego, entered a global license agreement with Stanford University School of Medicine. The deal allows Denovo to develop and commercialize DB-102 (enzastaurin), its lead compound, to treat pulmonary arterial hypertension (PAH) and emphysema. Read More
Translate Bio Inc., of Lexington, Mass., has filed for an IPO to raise up to $115 million. The company is developing an mRNA therapeutic platform with lead product candidate, MRT-5005, targeting cystic fibrosis, and a phase I/II trial has been initiated. The company plans to list on Nasdaq under the symbol TBIO. Read More
