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Editor's Note: If you missed Adam Feuerstein's play-by-play report of the goings-on at this major biotech event this weekend, here's a replay of the action.
Saturday, June 5
ASCO Report: Kidney Cancer Confusion
6/5/04 1:58 PM ET
Day one at ASCO: It's been a busy morning of listening to presentations and running around grabbing data posters (and of course, talking to buy-side sources.) There's too much data to discuss here now in detail, but I do want to offer my impressions of what I've seen. I'll try to dig in deeper later in a column, or two, or three!
Topic No. 1: Who has the best kidney cancer drug? As it was before ASCO, it's very difficult to compare the efficacy of
BAY 43-9006 and
SU11248 -- different drugs, different trial designs. But with that said, my gut feeling is that the Pfizer presentation this morning was clearer and more easily understood than the Onyx presentation. This might hurt Onyx come Monday when trading opens -- fairly or unfairly, I really don't know.
SU11248 induced a 33% response rate in kidney cancer patients, and showed a median time to progression of 8.3 months -- much better than what you'd expect from these patients treated with currently approved drugs. By comparison, the Onyx trial design for BAY 43-9006 is much more complex, even confusing. Read the company's press release
here for the numbers. In some ways, you can argue the BAY 43-9006 data are better than SU11248, but measurement criteria used by Onyx are more lax than what Pfizer used. And like I said, the trial design makes it hard to really tease out the drug's efficacy.
I can tell you that fund managers walked out the presentation scratching their heads. Onyx bulls were defending the data but those on the fence pointed to the Pfizer data and wondered if it wasn't as good, or better. Bottom line: Which drug gets to the FDA first? That's the big question. I wish I had an answer. I talked to people this morning who feel that Pfizer might be able to file first; others said no way, Onyx will file first. What this tells me is that there is uncertainty on Wall Street, and we all know how the market feels about uncertainty. Until Onyx gives investors a crystal-clear explanation of the BAY 43-9006 data and outlines a clear regulatory path to the FDA, investor questions will persist.
Onyx has gone from $60 per share in early May to the low $40s today, obviously because of the concerns I highlighted above. Is the selling done, or will today's presentation add more worries and prompt a further selloff? Don't forget, Onyx presents data on BAY 43-9006 in skin cancer tomorrow -- that data (chatter is that it's good) will also impact the stock's trading on Monday.
ASCO Report: ImClone Wins, Millennium Surprises
6/5/04 2:01 PM ET
Topic No. 2:
Erbitux data in head and neck cancer. The study was a definite success. (Read
my column for more details.) The investor worry coming into ASCO was that Erbitux would show positive trends in survival and the other endpoints, but wouldn't hit statistical significance. Well, put those worries aside. The study hit significance across its primary and secondary endpoints.
ImClone takes top prize on Day One of ASCO -- everyone I spoke with was really impressed with the data.
Topic No. 3:
. The Velcade data in non-small cell lung cancer is better than expected. The company had told us in January that Velcade was showing early activity in lung cancer patients, but skepticism over just how much efficacy ran rampant across Wall Street. To its credit, Millennium surprised everyone with 10% response rates as monotherapy, 15% response rate with combination of Velcade and Taxotere (a chemo drug), according to data presented today. These are interim findings from a small phase II study, but it seems clear that Millennium execs are not conning us when they talk about Velcade possibly working in the lucrative market for solid tumors -- at least in lung cancer.
Sunday, June 6
ASCO News: ImClone's Erbitux Continues to Shine
6/6/04 12:04 PM EDT
ASCO Day Two: There was one Erbitux abstract of note this morning, adding to yesterday's good news for ImClone. A phase II study conducted by Merck KGaA evaluated the use of Erbitux and the chemo regimen known as FOLFOX-4 (which contains oxaliplatin) in patients with first-line metastatic colon cancer. In a preliminary analysis of 42 patients, 2 patients (5%) had a complete response, 32 patients (76%) had partial response.
These are good data. In these colon cancer patients, the addition of Erbitux to FOLFOX-4 essentially doubled the overall response rate (complete responders and partial responders combined.) The reason this study is important is that it shows evidence that Erbitux might be effective in front-line treatment of colon cancer patients -- currently the domain of
Avastin. (Recall, Erbitux is currently approved for use in third-line, or later stage colon cancer patients.)
Avastin is a blockbuster drug in the making because it boosted survival in front-line colon cancer patients when used in combination with a different chemo regimen, but to date, there is no data to show how well Avastin works with FOLFOX-4. Now be careful, today's Erbitux data is preliminary and there won't be any survival data from this study. But what this data does show is that ImClone and Merck KGaA are not content to cede the lucrative front-line colon cancer setting to Avastin. One day, you might see Erbitux competing with Avastin for front-line colon cancer patients.
One other Erbitux note: I walked the massive exhibit hall yesterday, and Erbitux dominates the room. Both
and Merck KGaA have enormous booths set up to market Erbitux. What's funny is that ImClone has its own booth, but it's puny by comparison. If you're an ImClone investor, you gotta love that: ImClone lets its partners spend the big bucks to promote Erbitux while ImClone just sits back and cashes the checks!
More ASCO: Onyx Melanoma Data Coming Later Today
6/6/04 12:06 PM EDT
Onyx Pharmaceuticals presents additional data for the combination of BAY 43-9006 and two chemo drugs (cisplatin and paclitaxel) in metastatic melanoma patients. I've spent a lot more time talking to buy-siders about yesterday's kidney cancer presentations. I read back over what I wrote yesterday and I still think it's an accurate representation of the feeling on Wall Street, albeit with one caveat I want to clarify.
There seems little doubt that BAY 43-9006 is an active drug, especially in kidney cancer patients. I haven't talked to anyone who seriously doubts this. Therefore, if you're an Onyx investor with a long-term outlook, you shouldn't be concerned. The uncertainty really centers on the current phase II study: Will Onyx be able to use this study to seek approval quickly? Or will the company have to wait for interim or final data from its ongoing phase III study in order to file? If you're a trader or short-term investor, you've already lived through a good bit of volatility in the stock over the past month, and you could be in for more.
ASCO News: Abgenix, Amgen Bring Their Own Colon Cancer Drug to the Big Show
6/6/04 12:27 PM EDT
With all the news about Erbitux, let's not forget that
are also developing an EGF inhibitor drug, ABX-EGF (also known as Panitumumab.)
This morning, Abgenix presented updated data from a phase II study of ABX-EGF as a standalone therapy in patients with advanced colon cancer who had failed two or three other chemo treatments. Treatment with ABX-EGF produced a partial response in 15 patients, or 10% of the 148 patients evaluated. This 10% response rate is the same efficacy presented at last year's ASCO meeting and is the same efficacy shown by ImClone's Erbitux in this patient population. The side-effect profile of ABX-EGF continues to look good -- better than Erbitux, which will be the drug's main marketing strategy if and when approved. Abgenix and Amgen are currently conducting a pivotal phase III study.
Yesterday, Abgenix presented early data from a phase II study that is testing ABX-EGF in combination with chemo against front-line non-small cell lung cancer. Efficacy data from 19 patients was presented -- one patient had a complete response, 4 patients had partial response for an overall response rate of 26%. The study continues and will enroll another 175 patients. Like yesterday's data from Millennium Pharmaceuticals' Velcade in lung cancer and Erbitux in lung cancer, you're continuing to see encouraging preliminary evidence that these targeted drugs show activity against lung cancer.
Oops, and I almost forgot. Genentech and
had their own lung cancer news yesterday: The combination of Avastin and Tarceve produced a 20% response rate in 40 patients with non-small cell lung cancer, according to preliminary results of a phase II study.
Onyx Melanoma Data Released
6/6/04 3:12 PM EDT
Onyx Pharmaceuticals released the updated data from its phase II combination study of BAY 43-9006 in melanoma (skin) cancer. Of the 35 patients evaluable, 14 patients, or 40%, had a partial response (tumor shrinkage of at least 50%), all of which lasted six months or more. At the time the data was analyzed, only three patients' disease had progressed at 10-12 months. (This shows a nice durable efficacy.) Another 15 patients, or 43%, had tumors that neither shrank, nor grew (disease stabilization).
The 40% partial response rate presented today compares to a 50% response rate when earlier data was presented late last year. But the drop in response rate is not surprising given the increasing number of patients analyzed from 14 last year to 35 today.
As I said earlier, BAY 43-9006 is being given in combination with cisplatin and paclitaxel in this study. Onyx is already planning a pivotal phase III study in melanoma. This data will be presented in about an hour at ASCO, I'll be there and will report back.
ASCO: The Sunday Finale
6/6/04 10:16 PM EDT
My last ASCO post for the night. (Sorry it's late, but I had to watch the season finale of
The presentation of the phase II combination study of Onyx Pharma's BAY 43-9006 in melanoma went without any surprises. The data presented followed the form I outlined earlier. The data seemed to be well-received, including during a discussion session after the presentation, conducted by Dr. Eric Rowinsky, a well-known oncologist.
The same could not be said for a presentation of the failed
phase III Genasense melanoma study -- updated survival data (if you could call it that) once again underscored why Genta was sent packing by the FDA and why the stock now trades with the fishes.
Genta was supposed to have a booth in the exhibit hall, but given the implosion, the company "donated" the space back to ASCO, which turned the smallish square of carpet into a lounge with chairs and couches. On Saturday, I hung out there with several former Genta institutional investors who were long and short when it mattered. It was a funny get-together and testament to the fact that folks on opposite side of an even contentious trade can be friends. One of the former Genta bulls was particularly gracious, joking that the Genta "booth" reminded him of the ancient ruins of a long-lost extinct city.
Lastly, one more ImClone item to get your Monday rolling. Smith Barney Citigroup biotech analyst Yaron Werber upgraded ImClone Sunday night to a buy from hold, raising his price target to $105 from $90. He also raises his EPS forecasts for the years 2005-2008.
I'll be back Monday to see how biotechs trade.