ASCO 2019 Preview: Presentations to Keep An Eye On
American Society of Clinical Oncology (ASCO) meeting is always an exciting week in the pharma industry as multiple companies showcase their clinical research into various cancers.
The excitement gets underway on Friday in Chicago as companies unveil data from recent trials that could potentially change the way in which providers treat cancer. Below are a few presentations that will bear watching at ASCO.
Novartis – Swiss pharma giant Novartis will present data from across its oncology portfolio at ASCO for multiple cancers, including breast cancer, melanoma, lung cancer and other solid tumors. Novartis will walk into ASCO with its head held high after winning approval from the U.S. Food and Drug Administration for a first-of-its-kind breast cancer treatment. The FDA gave the nod to Piqray, the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer. Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations. Piqray (alpelisib, formerly known as BYL719) in combination with fulvestrant, was approved by the FDA for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-),PIK3CA-mutated, advanced or metastatic breast cancer. Novartis will present data from the Phase III SOLAR1 trial which earned Piqray its FDA approval.
The company will also provide additional clinical analyses from its key radioligand therapy – Lutathera, the first ever approved Peptide Receptor Radionuclide Therapy. Lutathera was approved in January for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), an orphan disease.
Oncoceutics, Inc. – Philadelphia-based Oncoceutics, Inc. will showcase data from its ongoing trial assessing ONC201 in adult recurrent H3 K27M-mutant glioma. The oral abstract session presentation, entitled “Single agent ONC201 in adult recurrent H3 K27M-mutant glioma” will describe the clinical experience of ONC201, in adults with recurrent H3 K27M-mutant glioma. ONC201 is an orally active small molecule DRD2 antagonist. The presentation will discuss a cohort of adults with H3 K27M-mutant glioma patients who have received ONC201 after failure of available therapies. The results will include assessments of radiographic response, progression-free survival and overall survival, as well as safety and clinical benefit. In addition, there will be an update on ONC201 in previously irradiated pediatric H3 K27M-mutant glioma that will be presented in a poster session.
OncoNano Medicine, Inc. – Texas-based OncoNano will share full data from its first-in-human study of ONM-100, an intravenously administered imaging agent. The agent was well tolerated and enables fluorescent visualization of tumor-positive margins and occult disease in solid tumors during surgery, the company said. Low pH is a well-known indicator of diseased tissue and ONM-100 has the potential to act as a broadly indicated tumor agnostic imaging agent, OncoNano said. When used by surgeons, ONM-100 is delivered to the tumor and fluoresces in the acidic tumor microenvironment. This enables surgeons to visualize the tumor during surgery using existing near infrared surgical cameras. OncoNano recently concluded a Phase 1 clinical trial for ONM-100.
AstraZeneca – British pharma giant AstraZeneca will also showcase some of its oncology assets during the conference. Of note is data regarding the company’s Phase III POLO trial showing its market-leading PARP inhibitor Lynparza (olaparib) as a possible first-line treatment in metastatic pancreatic cancer (mPC) patients with a germline BRCA mutation. In February, the company announced the data from the late-stage trial that showed Lynparza provided a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy. Lynparza received Orphan Drug designation from the FDA for pancreatic cancer in 2018, and AstraZeneca plans to file for approval in the second half of 2019.
Another study of note that AstraZeneca will share is the PACFIC trial demonstrating Imfinzi three-year overall survival in Stage III non-small cell lung cancer. Imfinzi is the first immunotherapy approved for stage III lung cancer. Last fall AstraZeneca released results that showed Imfinzi (durvalumab) significantly improved OS. Regardless of PD-L1 expression compared to placebo, the drug decreased the risk of death by 32 percent, the company said. Data also showed positive results in progression-free survival.