Seattle Genetics, Inc. (SGEN), a global biotechnology company, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.
The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold. Two phase 1 trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent). These studies are SGN-CD33A monotherapy, including a subset of older AML patients in combination with hypomethylating agents, and SGN-CD33A combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients. No new studies will be initiated until the clinical holds are lifted.
Maintaining $43 Fair Value Estimate for Seattle Genetics Following News of Clinical Trial Holds by Kelsey Tsai | 12-29-16
We are maintaining our $43 per share fair value estimate for Seattle Genetics following news of a clinical hold on the company’s early-stage programs evaluating SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia (AML) patient populations. Liver toxicity was found in six patients who received stem cell transplantations, and four have died so far. The clinical hold halts the company’s phase I/II trial and stops enrollment for its two phase II trials as the FDA and Seattle Genetics evaluate whether the liver toxicity is linked to SGN-CD33A. While we believe the news increases the risk for the company’s SGN-CD33A program, liver toxicity is common following stem cell transplant and the holds do not affect the later-stage trials evaluating the drug in populations that do not receive transplants.
Our valuation of Seattle Genetics is still driven by the future outcome of a first-line Hodgkin’s lymphoma study for Adcetris (currently approved in the relapsed/refractory setting). We assume the probability-weighted contribution of SGN-CD33A sales will be a fraction of the $1.5 billion in probability-adjusted peak sales for Adcetris.
Our estimated contribution of future SGN-CD33A sales primarily rests on the outcome of the phase III trial CASCADE, which will test the drug candidate as a frontline therapy for older AML patients and is not affected by the clinical holds. The older AML population typically does not undergo stem cell transplantations due to their fragile status and presents the largest market opportunity for SGB-CD33A, in our view. The company’s phase II program in frontline myelodysplastic syndrome also remains unaffected and is currently enrolling patients. We believe successful commercialization of SGN-CD33A would add much-needed diversification to Seattle Genetics’ portfolio.
Seattle Genetics gets a PhIII win for Adcetris, but shares slide as frets linger
by john carroll — on June 26, 2017 06:45 AM EDT Updated: 09:49 AM
Seattle Genetics $SGEN has had a rough Q2 as its lead experimental therapy was put back on hold, forcing investigators to scrap Phase III shortly after the biotech had to drop a deal with Immunomedics. But it’s winding up the quarter with a major win in its favor, posting a hit in its closely-watched Echelon-1 study for frontline Hodgkin lymphoma.
The big biotech says that its flagship therapy, Adcetris, combined with a trio of standard drugs beat a 4-drug mainstay cocktail therapy in frontline Hodgkin disease for modified progression-free survival over a lengthy two-year stretch. The Adcetris package excluded bleomycin, which has been linked to a higher rate of lung toxicity and was used in the 4-drug combo control.
Clay Siegall Company execs tell me that they’re prepping an FDA application anticipated for later this year. Seattle Genetics controls the US and Canadian markets for Adcetris, with its partner Takeda taking on the rest of the world.
Analysts have been watching this key catalyst closely, looking to see if Seattle Genetics has a good chance of significantly expanding its revenue from Adcetris. The answer to that would appear to be a conditional yes, based on the biotech’s top-line data.
The Adcetris combo hit a two-year modified PFS rate of 82.1% compared to 77.2% in the control arm — a 4.9 point, or 6%, improvement. That’s statistically significant, but not the wider, double-digit margin that the bulls have been looking for, according to a recent deep dive on this subject from Leerink.
Analysts there have noted that without a 10%-plus margin in its favor, payers may just stick with the cheaper standard. The difference could amount to hundreds of millions of dollars for Seattle Genetics by 2025.
Investors weren’t happy with the numbers. Seattle Genetics’ shares dropped 11% as the data sank in on Wall Street. Some of the early reactions on Twitter were also critical.
Follow Brad Loncar ✔ @bradloncar 82.1% vs 77.2% (hazard ratio=0.770; p-value=0.035) looks more marginal than meaningful. 3:55 AM - 26 Jun 2017 Retweets 11 11 likes Twitter Ads info and privacy You always prefer a better response, Seattle Genetics CEO Clay Siegall told me in a preview of the announcement. But this marks a clear win for patients and a plus for the company as Siegall remains determined to make Adcetris a billion dollar-plus blockbuster.
“We did a pretty audacious trial,” Siegall says. “People said you’re trying to build on something that already looks pretty good…There wasn’t a lot of headroom.”
Adcetris and the combo delivered a 23% reduction in risk of progression, he says, building the number of durable responses among patients who are often diagnosed in their twenties and thirties. In addition, he says, doctors clearly want to eliminate bleomycin and the risk of lung toxicity, offering another advantage for Adcetris.
Seattle Genetics added that an interim look at overall survival rates — the secondary to watch — appeared to be “trending” in its favor at the interim point. That’s not unexpected. It will probably take 4 years to reach a conclusion on OS, says the CEO, in this population.
There’s also likely to be continued chatter about investigators’ use of “modified” PFS in the study.
Rather than stick with tracking the time until disease progression, researchers modified the endpoint to include the use of an additional therapy for patients who had a “certain lack of response,” says the CEO, who added that that is a simplistic definition. If approved, says Siegall, this would be Adcetris’ 5th OK, with earlier expansions helping to continue to widen the market for their drug.
Siegall also says that the pipeline at Seattle Genetics continues to offer some stellar prospects for beefing up its portfolio of marketed drugs. The biotech remains ready to do new deals, he says, but only on an ‘as wanted’ basis as opposed to an ‘as needed’ basis.
“We think Adcetris has an excellent chance of being a billion-dollar drug in the US,” says the CEO. The next year will provide some insights into just how likely that is.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6