This week, several advances in the oncology world brought new hope to patients suffering from lung and pancreatic cancer. Roche’s Tecentriq gained new first-line lung cancer use while a Roswell Park Team developed a two-pronged approach to pancreatic cancer that offers promise. Oncologists received ASCO’s revised guidelines for patients and caregivers during COVID-19. The guidelines offer immediate and short-term steps for oncology practices to help them deliver diagnostic and treatment options safely during the pandemic. More top stories are in this week’s Innovation Partners BioBlog.
Roche’s Tecentriq gains new first-line lung cancer use
The FDA has approved Roche’s Tecentriq (atezolizumab) based on an interim analysis from the phase 3 IMpower110 study, which showed Tecentriq monotherapy approved overall survival by 7.1 months compared with chemotherapy in people with PD-L1 expressed on at least half of their tumour cells. Tecentriq has been approved in untreated adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high levels of the PD-L1 biomarker, with no EGFR or ALK mutations. Roche also noted that Tecentriq’s safety profile is consistent with its known safety profile and had no new safety signals. The company hopes oncologists will prescribe Tecentriq instead of Merck & Company’s Keytruda, the leading competitor.
Special Report Provides Guidance to Oncology Practices on Resuming Cancer Care During COVID-19 Pandemic
The American Society of Clinical Oncology (ASCO) has released a new guide for physicians caring for cancer patients during the COVID-19 pandemic. The guide provides oncology practices with detailed immediate and short-term steps to take to protect both patients and healthcare workers during the pandemic. Practices throughout the United States have taken many steps to ensure the safety of both their patients and the staff caring for them. Now, however, as restrictions are eased through most states, oncology practices are starting to work on plans to reopen and restore safe access to diagnostic, treatment options, and other services.
Moderna taps $1.34B stock offering to bankroll its promising COVID-19 vaccine
Cambridge biotech company Moderna is looking to raise $1.34 billion through a public stock offering. The company plans to use the funds raised for the distribution of mRNA-1273, its mRNA vaccine candidate against the novel coronavirus. A phase 1 test of 8 individuals resulted in such promising outcomes that the stock price jumped 20%. Moderna was founded in 2009 and has already attracted attention from venture capital firms. It went public in 2018. Now, it is putting a large part of its efforts behind its potential COVID-19 vaccine.
Teva bails on price-fixing settlement in gamble on its role fighting COVID-19: report
A federal probe focused on generic-drug price fixing appears to be intensifying. Teva, one of the companies suspected in the fraud, walked out on a settlement agreement with the feds, seemingly daring the government to pursue criminal charges when it has been one of the leaders in the response to COVID-19. The New York Times reported that Teva is betting that its role in aiding the U.S. coronavirus response, including donating millions of doses of antimalarial hydroxychloroquine sulfate to hospitals, will make the Justice Department hesitate before it files charges.
Roswell Park Team Proposes Strategy for Making Pancreatic Tumors Respond to Checkpoint Inhibition
A potential treatment for pancreatic tumors has been created by a combination of experts in precision medicine and immunology. A team headed by Agnieszka Witkiewicz, MD, and Erik Knudsen, PhD, at Roswell Park Comprehensive Cancer Center and published in the journal Gut suggest a combination treatment approach that can make some breakthrough immunotherapy drugs effective for more patients with pancreatic cancer. The study opens up a possibility for improving outcomes for patients with a notoriously difficult-to-treat cancer using a combination of existing drugs. The team tested a combination of CDK4/6 inhibitors and MEK inhibitors. The results indicated that together, the drugs slowed the growth of pancreatic cancer tumors in preclinical cancer models.
States face looming crisis over Medicaid growth, which could trigger changes for providers and payers
A decline in tax revenues caused by the pandemic stay-at-home orders and an upsurge in Medicaid enrollment may create a major budget crisis in some states. Experts predict that states may need to initiate payer cuts or other measures to contain costs. Rapidly rising unemployment is predicted to increase the number of people seeking to enroll in Medicaid while at the same time companies remain idle and sales tax revenues dwindle. In the past, states have limited provider payment rates and tightened drug formularies to downgrade utilization to contain costs.
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer
The Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy. Patients received rucaparib 600 mg orally twice daily and concomitant GnRH analog or had prior bilateral orchiectomy. Rucaparib previously was granted Breakthrough Therapy designation for this indication.