Q1 Preview: AstraZeneca’s Oncology Pipeline Center Stage As ASCO Approaches
Executive Summary
Potential ASCO readouts and the recent setback for Fasenra in COPD will feature in AstraZeneca’s first quarter earnings presentation next week.
Sales figures for AstraZeneca PLC's oncology portfolio will be center stage during the company's first quarter earnings call next week - but the broader focus will remain on how well the big pharma can execute its pipeline plans.
Sales for the UK big pharma are expected to be down by around 3% for the first quarter of 2018, driven by continued generic erosion of the company’s established brands like Crestor and Symbicort.
Financial guidance for the full year in 2018 will likely remained unchanged; AstraZeneca has forecast that product sales will increase by low-single digit and core EPS for the year will be in the range of $3.30-3.50.
Investors will be paying attention to the progress of Tagrisso (osimertinib) and Lynparza (olaparib) in the first quarter, as key elements for AstraZeneca’s oncology franchise. Morgan Stanley analysts said in a May 11 note that they would monitor closely sales of these drugs, particularly “the evolution of sales in China.”
Upcoming Catalysts
AstraZeneca will report several pipeline updates over the next few weeks, with a number of oncology clinical updates expected during the American Society of Clinical Oncology’s (ASCO) annual meeting, to be held in Chicago, June 1-5. Market spectators will be looking for comments on these events during the company’s first quarter earnings call on May 18.
Before the end of the second quarter, AstraZeneca will present results for Lynparza from a late-stage trial in first-line ovarian cancer. The FDA first approved olaparib in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The drug was also approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in Aug. 2017.
Top-line results are expected between now and the end of June from the pivotal Phase III SOLO-1 trial, which is testing Lynparza as a maintenance monotherapy in patients with BRCA-mutated advanced ovarian cancer following first-line platinum-based chemotherapy.
The company will also report data for selumetinib in thyroid cancer in the coming few weeks. AstraZeneca is expected to file a new drug application later this year following the top-line data readout for selumetinib from the Phase III ASTRA trial. A European regulatory filing to the EMA is also slated for this year. Thyroid cancer would represent a first filing for selumetinib.
Selumetinib is a novel, selective, non-ATP-competitive inhibitor of MEK (MAP-erk kinase) that has demonstrated nanomolar activity against isolated MEK enzyme and in numerous cancer cell lines. As well as thyroid cancer, the drug is being tested in melanoma, solid tumors and is in a number of investigator initiated trials.
However, the drug has stumbled in previous late-stage trials, turning up mixed data in lung cancer and melanoma. Clinical programs in non-small cell lung cancer have been suspended. (Also see "Another Late-Stage Failure For AstraZeneca's Selumetinib" - Scrip, 9 Aug, 2016.)
Finally, AstraZeneca is expecting key data readouts for its PD-L1 inhibitor Imfinzi (durvalumab) in head and neck cancer before the end of June. Results from the Phase III KESTREL study for Imfinzi as a first-line treatment for head and neck squamous cell carcinoma (HNSCC) are likely to one of the key presentations at ASCO next month. AstraZeneca will also report Phase III data from the EAGLE trial, which is testing Imfinzi monotherapy and Imfinzi in combination with tremelimumab versus standard of care therapy in patients with recurrent or metastatic HNSCC.
ASCO will announce its program and abstracts to be presented later this week.
Fasenra Q&A
AstraZeneca's hopes of turning its asthma biologic Fasenra (benralizumab) into a franchise from a single-indication product hit a stumbling block last week after the drug failed in a chronic obstructive pulmonary disease (COPD) Phase III study, the first of two eagerly awaited readouts. (Also see "AZ's Fasenra Hits First Hurdle Hard In COPD Study " - Scrip, 11 May, 2018.)
Analysts and investors will be awaiting further updates for the future of this product during the company’s Q1 earnings call.
AstraZeneca announced top-line results from the GALATHEA trial on May 11 that reveal that Fasenra did not meet the primary endpoint of a significant reduction of exacerbations in patients with moderate to very severe COPD. The study is part of VOYAGER, which is currently the largest COPD biologics development program in the world with close to 4,000 patients.
Analysts at Morgan Stanley issued a note on May 11 saying that the COPD failure was "a significant negative as the expectations were building up for this indication," but all hope is not lost. Further results are expected before the end of the second quarter for Fasenra from the TERRANOVA trial. This study is evaluating the efficacy and safety of three Fasenra doses in patients with moderate to very severe COPD with previous exacerbations.
Fasenra, the company's first respiratory biologic, is already approved in the major markets for severe eosinophilic asthma.