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AstraZeneca's David Berman talks chemotherapy, immuno-oncology and trial design

? Immuno-oncology will replace chemotherapy for some cancers

? All IO research programs have a China-specific angle

? Companion diagnostics embedded in AstraZeneca's strategy

David Berman is senior vice president of Cambridge, U.K.-based AstraZeneca PLC's immuno-oncology franchise, where he heads up the late-stage programs. Berman joined MedImmune, the biologics research and development arm of AstraZeneca, after working as head of Bristol-Myers Squibb Co.'s immuno-oncology exploratory development team, where he had been in charge of late-stage development for a decade. Prior to this he was a pathologist at the National Cancer Institute of the National Institute of Health. Berman spoke to S&P Global Market Intelligence on the sidelines of the Financial Times' healthcare conference in London.

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David Berman

Source: AstraZeneca

We are at a particularly exciting time with regard to immuno-oncology but there has also been a lot of talk of irrational exuberance. Do you see IO replacing chemotherapy?

I do. I don't know if it will completely replace chemotherapy, but in some tumors I think it will replace chemotherapy — for example in second-line bladder cancer, where we have approval for durvalumab [also known as Imfinzi]. Before, there were chemotherapies that were just not very active so now those chemotherapies have been replaced in second-line lung cancer, and first-line lung cancer remains to be seen.

We have our Mystic trial and we're looking forward to a read-out. We also have a chemo combination trial because the interesting thing is we see, no matter what data you give oncologists, sometimes it's hard to get them off of regimens that are very active. And so we at least want to provide the option for doctors.

Making up a potential market of 20% to 30% of global cancer patients, how much more focused are you on IO toward the Chinese market?

All of our IO programs have a China-specific aspect to them. And if we don't include them in our clinical trials as an extension or as part of the main enrollment, then we always consider should we do a separate Asia- or China-focused trial.

How long has this been part of the trial design?

At least for the couple of years I've been at AstraZeneca. And I think it partly reflects AstraZeneca has such a heavy investment in China; it's the second-largest global [market]. So for example, we had Mystic. We were not able to include China in the enrollment so we are conducting a separate China-focused trial called Pearl [expected to read out in 2020]. That reflects the importance we place on China. Neptune was able to enroll patients from China and Danube, which is our first-line bladder phase 3 trial, will also enroll patients from China. Pearl is predominantly China but also includes other local Asian countries and Russia, interestingly, also.

Will you roll out the Tagrisso strategy of genetic testing to tailor the right medicines to the right patient population?

I think our strategy really is companion diagnostics. Over 80% of all of our pipeline have a diagnostic. And I can tell you that when I was over at MedImmune, all of our IO molecules that we [were] moving into clinic have a diagnostic attached to them. Or at least a hypothesis for a diagnostic.

Are you developing those diagnostics in-house?

We do it where we can, otherwise we partner. Sometimes you have to partner with a company that exclusively focuses on that platform.

How much interaction do you have with the Food and Drug Administration when it comes to trial design? Is there a very close dialogue?

Absolutely. In the phase 3 space that I work in now, we come up with our design, then we pressure test that with actually global health authorities not even just the FDA, but we speak with the EU, Japan — with all the major regulatory bodies, because these trials take so long and they are so expensive, you don't want to go in there with a trial design that's not going to be acceptable. It's actually probably not that well appreciated how collaborative and helpful health authorities are — to their credit. Because I think they want to have trials at the end that they feel are robust enough, so it's also in their vested interest.

What about the Chinese FDA?

The Chinese FDA regulations are evolving actually, even as we speak. In the past couple of months, they're released some new regulations suggesting that they can speed up their clinical trial process. Historically it's been really long, you submit that clinical trial application and it could take up to 18 months, which is very hard if your trial takes a year to enroll. That's why it's been hard to sometimes get Chinese patients involved but they've just released new regulations.

In the future, will you have separate conversations with the CFDA or will they be part of the global regulatory framework?

Historically, you had to have a submission underway or an approval to even start talking, so they could have a reference approval. But part of the new regulations is that you don't really need that. So the requirements will be very similar to Japan. Because it's a different genetic makeup, they want to make sure that the [pharmacokinetic data] is acceptable, the safety is acceptable, that the dosing regimen is acceptable. So I think you're always going to need some type of minimum number of Chinese patients or Japanese patients.