What company is advancing in cancer immunotherapy? Who just announced a new Phase 3 study in patients with advanced inoperable breast cancer? What drug missed its goal in a mid-stage study of acute myelogenous leukemia (AML)? These are just some of the questions that can be answered by going to Pipeline Online at www.obroncology.com.
Over a dozen new oncology-focused companies and roughly 40 new pipeline products have been added to Pipeline Online since our May launch. This is in addition to the hundreds of updates we’ve been keeping track of to what we believe is the most comprehensive oncology pipeline database widely available on the Web.
With that said, a few of the noteworthy additions and updates that we’ve made to the database include:
Biovest International—a company that is contributing to the advancement of cancer immunotherapies/vaccines. Featured at an ASCO Plenary Session, Biovest presented data on their immunotherapeutic vaccine -- BiovaxID™ -- in Phase 3 development for follicular non-Hodgkin’s lymphoma.
After high-profile setbacks to immunotherapeutic companies such as Favrille, Cell Genesys and Genitope, Biovest International is renewing interest in the field that many feel is making a “comeback” since the positive data delivered by Dendreon/Provenge® earlier this year.
Following the lead on immunotherapeutics, other biotech firms updated in Pipeline Online include Merck/Oncothyreon’s Stimuvax®, and Apthera’s NeuVax™. Merck and Oncothyreon announced a new Phase 3 study of Stimuvax in patients with advanced, inoperable breast cancer while Apthera recently received SPA approval for its planned Phase 3 study of NeuVax in advanced breast cancer.
That brings the total in the Pipeline Online database to 8 immunotherapies in Phase 3 development ranging in tumor type from lymphoma and melanoma to prostate, head and neck, liver, and lung.
In addition to the immunotherapy class in our database, we have over 350 drug classes to search, more than 160 companies listed, 40 tumor types recognized, and over 500 products.
Other news to be gleaned from the database includes Cephalon announcing lestaurtinib missed its goal in a mid-stage study of AML. The company stated the drug did not improve survival compared with standard chemotherapy.
Also updated is Immunogen’s pipeline after the announcement that they would discontinue a Phase 2 study of IMGN242 in gastric cancer due to slow progress.
On the other hand, Oncogenex recently announced that they are set to proceed with its Phase 3 study of its lead product candidate, OGX-011, in patients with hormone refractory prostate cancer.
Clavis Pharma, another new addition to Pipeline Online, announced a registration trial is being planned based on positive results from a Phase 2 study of elacytarabine in patients with late-stage AML.
One of the key elements to the continued success and usefulness of Pipeline Online is the dedication we have to maintaining the accuracy and depth of information. We do this through our constant monitoring and endless pursuit of all oncology news, events, and information that we use to produce OBR daily, Oncology Business Review, and our newest product, OBR green.
To get more details on all these resources, please visit our Web site at www.obroncology.com.
This year’s annual meeting of the American Society of Clinical Oncology (ASCO) is the first to be held since the new PhRMA guidelines regarding pharmaceutical industry giveaways went into effect—which is to say, it was the first ASCO without toys. Gone were the wind-up mouse models, squeezable brain-shaped stress balls, twisty-puzzle molecules, travel kits, tote bags and penlights; and gone too, in fact, were even the handy (branded) pens. In brief, it was the first ASCO sans chotchkies.
The ban of all such items, frivolous and otherwise, dates to January 1st of this year, beyond which time pharma companies were to voluntarily withdraw any offers of anything which might be construed as exerting influence, or currying favor with healthcare providers. This prohibition includes amusements both macro (trips, events, dinners) and micro (notepads, calendars, cups) and even veers into educational activities such as CME.
While the potential impact on educational programs has not been fully realized, the effect of banning toys and entertainment was immediate: there were times when the ASCO exhibit hall looked like a ghost town. “It’s a very different world out there,” intoned one grim-faced drug rep, as he gazed beyond the confines of his sparsely populated booth.
Indeed, as I toured the exhibit hall, the jovial, near carnival barker-like drug rep of old was not to be found and in his stead was the serious, the sedate, and the concerned: “I kid you not, I’ve got ten cases of mousepads in my basement. What am I suppose to do with this stuff?” Perhaps the glut of giveaways has spilled over onto eBay where a search for pharmaceutical pens yielded more than a hundred auctions. If this is PhRMA guidelines related, I do not know.
Only the inexperienced were at ease. An ASCO first-timer stood serenely by his supply of renal function posters (certain educational materials are allowed) and marveled at how polite oncologists were as compared to other specialists he had experienced. “It’s so nice,” he remarked, “There’s no grabbing,” To which a veteran rep standing nearby responded, “That’s because there’s nothing to grab.”
It will take time to adjust, but on the whole, pharma companies and their reps are resolved to the new paradigm, and, for lack of choice, are determined to find their way. Celgene, instead of offering a monogrammed laser pointer as a prize for winning a quiz now donates to charity in your name; Pfizer is now exclusively reliant on the popularity of their perennial offering a CD ROM of ASCO abstracts; and Genentech, the reigning king of gadget-land introduced their cosmic-looking “orb”, a beachball-sized touch-screen device that highlights their technology.
While pharma is readjusting, physicians are, for the most part, relieved. “Several years ago [one company] gave out these horrible bags that people were dragging behind them that we couldn’t stand – they got in everybody’s way,” said Jordan Berlin, Vanderbilt University. Practicality also appealed to Stefan Korec, Alamagordo, New Mexico, “On the one hand it’s great – the toy collectors aren’t there so we have more time to spend in the booth and talk to the reps. On the other hand some of those toys were useful, even instructive. But I agree with the no toys policy… now if that could only lead to a reduction in drug prices!” Korec’s was a common observation; gone were the snaking lines of highly paid professionals waiting for a chance to win a $10 memory stick. Reps were accessible; substantive conversations could be had.
So, there was that. But was it less fun? “My life is pretty fun,” said Halle Moore, Cleveland Clinic, “I don’t need pharmaceutical companies to make my life fun.” And the fun not had in the exhibit hall extended to the lack of receptions, or novel field trips. This was no loss to Adam Brufsky, University of Pittsburgh. “Frankly, I don’t need another trip to SeaWorld,” he said, and in his opinion the restrictive PhRMA guidelines were missing the forest for the trees. “There are a lot of different motivators for people in academic medicine, and money [in cash or prizes] is down the list.” He considers prestige to be the true coin of the realm. “Most of the malfeasance that has occurred in our business has to do more with people fudging data for grants, for promotion.”
Banning pens won’t have an impact on that. “Toys are fun,” Brufsky said, (as he thoughtfully sipped his Genentech-provided smoothie) “but it’s kind of insulting to believe that an oncologist could be swayed one way or the other just because you get a free jump drive that says Novartis on it. Hopefully we’re smarter than that.”