The annual meeting of the American Society of Clinical Oncology is important not just to cancer doctors, researchers, and patients but also to drug companies and their investors. More drugs are in development for cancer than any other disease, and the ASCO meeting can be a key moment to assess how well experimental medicines are doing. That's why Chicago's McCormick Place convention center is crawling not just with doctors but also with bankers and fund managers in fancy suits.
So who's winning and losing at this year's conference? To be honest, for the most part this year's meeting is a story of dead heats and unfinished competition, with no clear breakout successes or stunning routs. But there are some moderate wins and real setbacks. So let's round them up.
Loser: Companies developing breast cancer drugs – particularly Puma Biotechnology. Poor Puma – and, really, every company developing a new breast cancer drug – is getting hit by collateral damage from a failed GlaxoSmithKline study testing Tykerb (one of the drugs Glaxo just sold to rival Novartis) as an addition to existing treatments. The combo didn't help the patients in the study.
The problem is an earlier study testing whether the Tykerb-containing combo delayed disease when given before surgery did show benefit, and companies have been hoping to use studies like that to get breast cancer drugs approved faster. The Food and Drug Administration has even approved one drug – Roche's Perjeta – this way.
“The hope is that by getting the drug into the market, we ultimately will save lives,” says Clifford Hudis, ASCO's president and an oncologist at Memorial Sloan-Kettering Cancer Center. “That may ultimately be true for [Perjeta]. But if the question is can we routinely use the preoperative setting as a reliable test, the answer is maybe not.”
For his part, Richard Pazdur, the head of the office of oncology products at the FDA, said that the failed trial doesn't actually change the FDA's policy because it was already using the pre-surgery studies only as part of a larger picture of a drug's benefit. Perjeta, he says, was approved in part because earlier results had been strong; overall, it's not clear yet how to use these pre-surgery studies. Guidance to industry will be published in the coming weeks, he says. In the meantime, investors will fret about the prospects of companies looking to get early approval in breast cancer – including Puma.
Winner: GlaxoSmithKline, in part for reminding the world that it hasn't given up on cancer research by signing a deal with AdaptImmune for cancer cell therapies, but more for the early results in a triple combination therapy in patients with colorectal cancer who have failed Erbitux, the drug made by Eli Lilly and Bristol-Myers. The new combination therapy combines Erbitux with Glaxo's BRAF inhibitor dabrafenib, MEK inhibitor trametinib, and Amgen's EGFR inhibitor panitumumab. There was a promising (close to 50%) response rate from the combo. Other companies are working on similar combos, without the MEK. Still early, maybe not something you should invest in, but my second-favorite thing I saw this ASCO.
Winner: Any company working on therapies that aim to attack tumors with patients' own T-cells. I've already written that the positive results in cervical cancer bode well for this entire field, including Juno Therapeutics, Novartis, and Kite. My favorite thing from this ASCO.
Winners, sort of: All the companies, including Bristol, Merck, and Roche, developing PD-1 inhibitor drugs that stimulate T-cells to attack cancer. All the results are good, although nobody seems to have picked up any new edge against anybody else. The good news is these drugs continue to show efficacy in different kinds of cancer.
Loser: Eli Lilly. It's ramucirumab may get some sales in squamous cell lung cancer, where nothing else works. But this drug, with only a one month survival benefit, is still likely to be exactly what people are complaining about when they say that medicines have a small benefit and (I expect) high price tag.
Winner: AstraZeneca. AstraZeneca had to have a good ASCO after the crazy-high sales projections it gave as part of its battle not to be taken over by Pfizer. It did, with positive results for a new drug, code-number 9291, in lung cancer patients no longer helped by existing medicines and olaparib, for ovarian cancer. Pascal Soriot, AstraZeneca's chief executive, bragged to me that Astra had done a great job catching up to its competitor, Clovis Oncology, with 9291. When I challenged his sales forecast of $3 billion for 9291 – few, if any, of the other targeted drugs introduced over the past decade have been able to hit that mark – he said essentially that increased drug pricing might help him get there.
Loser: Clovis It's completely unclear whether Clovis or Astra has the better drug. But would you want to go against a drug giant that's desperate to prove it shouldn't just have sold itself with a roughly equivalent therapy? This could be a heated competition.
