Deals, Immuno-oncology

Looking for an oncology reboot, Sanofi, Regeneron shoot for a fast and flashy FDA OK of a promising new PD-1

There’s another PD-1 drug headed toward the market. And this fast-moving — and often overlooked — program is due to arrive at the FDA for marketing review in just a matter of months.

In an outline of Sanofi’s R&D work for the Q2 call this week, research chief Elias Zerhouni was clearly excited by the “fast-to-market strategy in the PD-1 space” that has been set up with its big development partner Regeneron $REGN.

Here’s what Zerhouni had to say:

At ASCO, we presented positive clinical data from a Phase I study, which showed that in patients with advanced CSCC (cutaneous squamous cell carcinoma — the second deadliest form of skin cancer behind melanoma), our PD-1 was associated with a 46% overall response rate, a 69% disease control rate, and was generally well tolerated. So, we look forward to the results of our registration study and are planning to submit to the FDA in metastatic cutaneous squamous cell carcinoma in Q1 2018.

We also started several studies of our PD-1 in other indications this past quarter, and these include a Phase 3 in first line non-small cell lung cancer and a Phase 2 in metastatic and locally advanced basal cell carcinoma.

Israel Lowy

With 5 PD-(L)1 drugs on the market and hundreds of studies underway to advance new approvals, the conversation in cancer circles these days tends to focus on whether these multiplying checkpoint inhibitors are becoming swiftly commoditized.

That’s not the way Sanofi and Regeneron are approaching this. At all.

As Regeneron’s top researcher on the program Israel Lowy told me at ASCO last summer, REGN2810 has convinced him PD-1 is a significantly better way to tackle the checkpoint hurdle than PD-L1. And the partners believe they can quickly start by leapfrogging the PD-L1s from AstraZeneca, Roche and Pfizer/Merck KGaA.

If he’s right, the implications in this megablockbuster field are enormous.

Elias Zerhouni

Zerhouni — who was diplomatic enough to thrive as head of the NIH — wasn’t willing to go that far right now. But for someone who’s looking to this drug to help reboot what has been a disappointing foray into oncology for years, he may be working up to it. Pressed on the point, he added:

Now, we, as I told you, believe that PD-1 is the right selection, the right target based on many data that we have generated ourselves and our partner, Regeneron. We do believe that there is a potential for PD-1 to be superior. We do not know that at this point. I wouldn’t venture to say that this is proven at this point. There are hints that indeed tell us that, and we’ve made a choice and this is the choice we’re making here. We’re going after PD-1. We do not have a PD-L1 in development.

A success here would set up Sanofi as a player in oncology, with a combo approach that could well help overcome the sting of past setbacks. Sanofi’s internal pipeline has been uninspired at best for years, with Regeneron lending a big hand to provide the kind of remarkable innovation that is needed for a reboot. That partnership has already landed several landmark drug OKs, and now it’s lining up another.

Look for the number 6 PD-(L)1 to hit the regulatory review path soon. It isn’t angling for last place.


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