Blog May 30, 2019

Meet You at ASCO!

asco19ASCO, the world’s largest meeting focused on cancer, is always one of the highlights of our calendar here at Bionest. This year is no exception and several of us are headed to Chicago for this year’s event, which is being held from May 31 to June 4. If you are going to ASCO, we’d love to hear from you and arrange to meet.


Each year, ASCO is organized around a pertinent theme. While previous years have also centered on precision medicine, this year’s theme, “Caring for Every Patient, Learning from Every Patient,” is focused on driving progress and expanding the reach and opportunities for more patients to benefit from this approach. Getting there will require the effective application of big data and analytics, new diagnostic tests and testing technologies, targeted therapeutic advances and effective treatment combinations, and better ways to make these advances available and more affordable to the community oncologist as well as the average patient. All of which we expect to hear about at the meeting.


Excitement about ASCO always reaches a high pitch when the abstracts from the conference are published, which happened on May 15. Here are a few things that we and others are eager to hear more about:


Late-breaking Clinical News


  • AstraZeneca/Merck & Co. will be presenting the first detailed data from the Phase 3 POLO trial of their PARP inhibitor Lynparza (olaparib) as a maintenance therapy in pancreatic cancer. In February, the companies announced that the trial had met its endpoint of improving progression-free survival (PFS) in BRCA-mutated pancreatic cancer patients who had not progressed following first-line chemotherapy. Lynparza appears to be on track for approval in this indication in 2020; the drug already holds approvals in ovarian and breast cancer. This places AstraZeneca/Merck ahead of competitors Pfizer and Clovis Oncology, whose respective PARP inhibitors, Talzenna (talozoparib) and Rubraca (rucaparib), are in Phase 2 testing in the pancreatic cancer setting. GlaxoSmithKine/Tesaro does not appear at this time to be developing their PARP inhibitor, Zejula (niraparib), in pancreatic cancer.


  • Novartis will present an update from the Phase 3 MONALEESA-7 trial of their CDK4/6 inhibitor Kisqali (ribociclib) in first line metastatic HR+/HER2- breast cancer. Industry observers are looking for the first significant benefit in overall survival (OS) with a drug from this class, as Pfizer’s Ibrance (palbociclib) narrowly missed its OS endpoint in the Phase 2 PALOMA-3 trial in postmenopausal metastatic HR+/ HER2- patients. Novartis’ MONALEESA-7 trial is testing Kisqali in premenopausal patients, who generally have a poorer prognosis. Kisqali received its first approval in 2017 for first line use in postmenopausal patients, which was expanded in 2018 to pre- and peri-menopausal women.


  • Pfizer/Astellas Pharma has been seeking to move the use of Xtandi (enzalutamide) to earlier stage prostate cancer. Based on their published abstract, we expect positive OS data from the ANZUP ENZAMET trial of Xtandi and standard androgen-deprivation therapy (ADT) against ADT alone in metastatic hormone-naïve prostate cancer patients. There has been a recent trend of next-generation hormone therapies showing strong efficacy in earlier-stage prostate cancer patients, and we anticipate that the Xtandi results will follow that trend.


  • Seattle Genetics and Astellas Phama will be reporting detailed results from the EV201 study of their antibody drug conjugate enfortumab vedotin in locally advanced or metastatic urothelial cancer. Topline results from the study, reported in March, announced a 44% overall response rate (ORR) in patients previously treated with both platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. While PD-1/PD-L1 inhibitors have a recognized role in the treatment of bladder cancer, effective drugs are still needed in the post-PD-1/PD-L1 setting.


Liquid Biopsy


Potential rivals Guardant Health and Grail will both have new data on their respective liquid biopsy technologies at ASCO.


Guardant showcased good data with their Lunar liquid biopsy test in colorectal cancer at AACR. At ASCO, they have two presentations. The first concerns the use of Lunar to monitor for disease recurrence, with the test’s positive predictive value of 93% and negative predictive value of 80% suggesting accurate and quantitative tumor detection in early stages of the disease. Guardant’s second abstract focuses on Lunar’s usefulness as a screen for colorectal cancer. While results to date are from analytical validation studies and not clinical samples, they suggest 99% specificity and 100% sensitivity for the test. The company recently announced plans for a 10,000-patient clinical trial of Lunar as a screening test for colorectal cancer, scheduled to begin in the second half of the year. These analytical results suggest good prospects for the trial’s success.


Grail will be presenting data on certain sub-studies from its huge Circulating Cell-free Genome Atlas study. One ASCO abstract suggests the ability of Grail’s test to detect the tumor tissue of origin with high accuracy. A second abstract suggests the test could identify patients with more aggressive disease, which could potentially prioritize those patients more in need of immediate treatment.


And the rest….


We found too many abstracts of interest to report in detail in this post. But we will also be on the lookout for noteworthy developments from Amgen, Roche, Macrogenics, Aduro, and Blueprint Medicines.