At a company the size of Johnson & Johnson, it would be easy for departments to become siloed, accomplishing only their own objectives without a vision of the bigger picture. But even in the earliest stages of science, units as fundamentally divided as clinical research and commercial strategy work together to achieve the pharma giant’s common goal.
As J&J pursues clinical results, Dr. Craig Tendler, vice president of late-stage development, diagnostics and global medical affairs in oncology, has to consider not only what’s happening in a non-small cell lung cancer trial but what the commercial landscape will look like so patients can ultimately benefit.
“The way I look at the commercial contribution before we even get on the market is trying to define those key attributes that are important to physicians and patients and being able to integrate that into a development program where the results will hopefully support that profile,” Tendler said.
So he teams up early with Biljana Naumovic, J&J’s president of U.S. solid tumor oncology, to ensure everyone is on the same page. Along with the research teams, Naumovic aims to define those key attributes at the outset.
“The primary end goal is to transform the lives of patients by changing the standard of care and supporting a long, fruitful quality of life,” Naumovic said. “We’re part of this discussion at the very beginning, so that before we go into the clinic, we’re defining where we want to go — for the past 20 years, we have done just that with very informed, passionate debates.”
If a program looks like it’s not going to change the standard of care, “we stop things that we do not think are going to hit the mark,” Naumovic said.
‘A huge responsibility’
When the baton makes its way from the clinical research teams to the commercial department, everyone needs to be on the same wavelength, Naumovic said.
“Bringing really strong data to then manage patients better is a huge responsibility,” Naumovic said, referring to the August FDA approval that stemmed from overall survival data in a late-stage study for EGFR-mutated non-small cell lung cancer with the drug combo of Rybrevant and Lazcluze compared with AstraZeneca’s Tagrisso, the current standard of care.
On the research side, patients stayed on the Rybrevant and Lazcluze combination treatment longer than with Tagrisso, Tendler said, noting that the combo provided better disease control, which is a selling point down the road. And that arises from early representation of the commercial perspective in clinical program design, he said.
“The beauty of having the commercial representation is that we have better insight as to what attributes should be integrated into the comprehensive development program,” Tendler said. “This idea that we have to look to not just bring a regimen that has enhanced progression-free survival but the factor that will convince physicians to use it in a higher proportion of patients is the survival data.”
At a conference with clinical experts like this past weekend’s annual conference of the European Society for Medical Oncology, Naumovic’s job is to distill the next steps into a commercial plan.
“Once the data is out, the oncology community has a million ideas for where to take it next,” Naumovic said. “And so we can create that together.”
In bladder cancer, for instance, J&J reported mid-stage data for a device called TAR-200 designed to sit in the bladder and release chemotherapy from within, showing a response rate of more than 83%.
“It’s a very clear example of an innovation being able to deliver an older drug in a new delivery device and having it get much more effective levels throughout the treatment cycle,” Tendler said.
Results like that give Naumovic some buzz to work with when the commercial strategy comes into play.
“This has never been seen before in localized bladder cancer, and to get there with a beautifully engineered device that stays in the bladder will be a radical change to what bladder cancer looks like once we bring it to the U.S. market in the beginning of next year,” Naumovic said.
The commercial influence
While science can only be done at its own pace, commercial demand can sometimes influence the direction in which a research team takes aim. A rise in colorectal cancer among young patients has troubled oncologists and caused companies like J&J to investigate new treatment options.
In a phase 1b/2 study for patients with metastatic colorectal cancer, a combination of Rybrevant and chemotherapy resulted in an almost 50% overall response rate.
“There has been no innovation in colorectal since [Eli Lilly’s Erbitux], and we’re talking several decades,” Naumovic said. “So like we did in bladder cancer and lung cancer, we’re coming to colorectal cancer the same way — there certainly is a resurgence of higher incidence in a younger population across the developed world because of diet, and we want to make sure we’re embracing that opportunity with the results that we have.”
Overall, J&J’s clinical and commercial teams have the same endpoints in mind — finding the right approaches to move the oncology field forward while keeping today’s patients at the center of the equation.
“We are a company that aims to put chemotherapy into the history museums where it belongs and focus on targeted therapies that will allow patients to live a longer and better life,” Naumovic said. “That’s where we think the field of oncology is going.”
