For José Baselga, the silver lining in the Covid cloud is that it could speed up clinical trials for cancer patients.
The social restrictions of the coronavirus pandemic have forced Baselga, executive vice president of oncology research and development at AstraZeneca, and others, including regulators, to rethink how they conduct clinical trials and communicate with patients and each other.
This matters for investors too: AstraZeneca, whose best performing business is oncology treatments, says the lessons learned could have benefits far beyond the current coronavirus crisis.
“When Covid-19 hit, we had to quickly ask: What do we do for our cancer patients who are receiving active therapy, who are in potentially lifesaving clinical trials?” Baselga said in an interview with Barron’s. “We decided to continue our clinical trials, to keep them open.”
But he also realized the trials were too complex, with too many hospital visits and laboratory tests required. “We could clearly simplify this,” Baselga said.
The Anglo-Swedish group is putting extra effort and investment into dealing with patients remotely, using online tools like telemedicine, electronic consent, and real-time data monitoring.
Baselga said the silver lining is that this will improve future programs, speeding them up, and saving money. “I have to say I’m actually quite excited about this,” he added.
More efficient communication isn’t only helping with patients: the U.S. Food and Drug Administration, the leading pharmaceuticals regulator, drafted guidance on new clinical trials during the Covid crisis in a matter of weeks, contributing to an acceleration of processes that can normally take months, Baselga said.
Typically, it takes seven months from the time that you have the concept of a trial to the time the protocol is completed, but Baselga said that in the pandemic, this part of the process has taken his team, along with collaborators, one month from beginning to end. Specifically, the recent CALAVI Phase II trials testing its blood-cancer treatment, Calquence, in patients hospitalized with respiratory symptoms of Covid-19.
Investors have spent months focusing on AstraZeneca’s potential Covid-19 vaccine candidate, which it is developing in partnership with the University of Oxford. The drugmaker released interim trial data on Nov. 23 that showed its experimental shot was at least 70% effective in protecting individuals from Covid-19 in late-stage trials in the U.K. and Brazil.
But AstraZeneca’s future earnings potential rests much more on cancer treatments.
“AstraZeneca is heavily reliant on its pipeline products and new launches for future growth; hence an accumulation of pipeline setbacks could jeopardize the ongoing turnaround. AstraZeneca’s pipeline success is heavily dependent on their success in immuno-oncology which is an increasingly crowded area with intense competition for ideas, talent and patient recruitment at key cancer centers,” said analysts at UBS, in a recent research note.
Oncology is the drugmaker’s best-performing division, with total revenue increasing 13% in the third quarter and up 24% in the year to date. The division now represents 43% of overall year-to-date revenue in 2020, compared with 38% for the same period a year earlier.
AstraZeneca’s oncology pipeline currently features 101 programs, with 36 in late stage development.
“What we are really pleased to see is that we have a diverse portfolio of five new oncology medicines that span multiple tumor areas with an equal mix of oral and injectable therapies, as well as regional diversity,” said David Fredrickson, executive vice president of AstraZeneca’s oncology business unit.
Growth has been led by sales of Tagrisso, its lung-cancer blockbuster, which saw sales up 30% in the third quarter compared with the same period in 2019. On Nov. 5, AstraZeneca also announced new European Union approvals for Lynparza in prostate and ovarian cancers.
Farxiga, which in May won FDA clearance to reduce the risk of cardiovascular death or hospitalization in heart-failure patients, brought in $525 million of sales in the three months to end of September—a 35% year-over-year rise. AstraZeneca plans to file for FDA approval for Farxiga in chronic kidney disease treatment at the end of the year.
There have been setbacks. On Nov. 12, the company said Calquence, proved ineffective in treating Covid-19 patients hospitalized with respiratory complications in two mid-stage clinical trials. AstraZeneca said data from the study will be detailed “in due course,” and stressed that the research in Covid-19 patients won’t affect existing or pending approvals for the cancer medicine.