Today's highest science, most fierce competition—and make no mistake, biggest gains—are coming from the oncology arena. In fact, there are more than 380 cancer compounds in development, according to a recent report by IMS Health, with almost 100 of them in Phase III trials.
The exciting news is that the investment in targeted therapies is paying off: Patients are living longer. But while these biologics are offering the very real benefit of extending survival, their price tag has made the payers restless. As a result, these incredibly efficacious—and expensive—drugs are jeopardizing the very way pharmaceutical companies commercialize cancer therapies.
What's emerging is a new set of rules for how to play to win in oncology. To offer insight and analysis in this area, Pharm Exec teamed up with Campbell Alliance to recruit Genentech's Bruce Seeley, Bristol-Myers Squibb's Robert LaCaze, and Pfizer's Alison Ayers for an executive roundtable. Together, these execs, and the companies they're from, represent the cutting edge in cancer care today. These front-runners say succeeding in today's oncology marketplace means not playing a game of selling, but rather starting in development to create cancer drugs with profiles that patients will demand. An edited transcript of their conversation, moderated by Pharm Exec Editor-in-Chief Patrick Clinton, follows:Days of Yore
PATRICK CLINTON: Today we are talking about how the oncology field has changed so we can make some predictions about the future. Let's start by looking back a decade: What was the oncology space like then?
AYERS: At that time, cancer treatment was really one size fits all—with the exception of breast cancer, where you had the hormone-responsive versus nonresponsive. It was very unsophisticated—no customization of treatment according to biomarkers or any prognostic factors. It was throwing cytotoxic drugs at the patient to the point of maximum tolerability and then backing off a little bit so that you killed the tumor before you killed the patient.
SEELEY: Back then, it was this smorgasbord of different types of cytotoxics, and there was a lot of experimentation. But, really, patients were being treated without a lot of guidance from clinical trials that showed bona fide, strong, conventional end points.
In today's regulatory environment, the type of clinical data that was available 10 years ago would have a very difficult time getting approved. For example, insurers were in many cases forced to pay for bone marrow transplants and other therapies without a whole lot of data to support those decisions.
NAEYMI-RAD: The average drug took around 500 days to get FDA approved, but oncology drugs only took 200—or less.
Many drugs were approved on Phase II data, and in some cases, single-arm studies. So companies did a few small trials, their drugs were approved quickly, and they went on the market without a lot of marketing investment—small number of sales reps, most of the focus was in medical affairs. You conducted a lot of post-marketing studies to examine where else your product could be used.
Ten years ago, oncology was kind of like the Wild West. Nowadays, it's quite the reverse. It's like that kid who wasn't popular in high school but now is at the reunion and everybody loves him, because he has matured and become more successful. Oncology is no longer the old dusty corner where you have to justify your existence. It's very much the place to be for a modern-day pharmaceutical—and especially biotech—company.