Data Confirms Zytiga is Killing Dendreon's (DNDN) Provenge, But Don't Put the Nail in the Coffin Yet

August 29, 2012 11:35 AM EDT
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Dendreon's (NASDAQ: DNDN) prostate cancer drug Provenge continues to underwhelm, but the game is still far from over said analysts at Baird.

Today, the firm highlighted new BioTrends prostate cancer survey data which showed that competing drug Zytiga has a strong presence in metastatic castration-resistant prostate cancer (mCRPC), with more than 60 percent of oncologists have trialed Zytiga. In addition, Zytiga is still seeing measurable off-label use, with docs saying 25 percent of their Zytiga patients are chemo-naïve.

On the implications for Dendreon's Provenge, the firm notes that while Zytiga is still taking share, it is less so. "Now 20% of docs indicate less Provenge use in favor of Zytiga (down from 31%); 72% indicate no change (up from 63%)," analyst Christopher Raymond said. Also, Zytiga well positioned to become dominant pre-chemo player. "Post-label expansion, oncologists indicate they will prescribe Zytiga to 56% of their asymptomatic/minimally symptomatic mCRPC patients, urologists 45%," the analyst notes. Docs increasingly expect to sequence Zytiga with Provenge. However, most docs still say Zytiga comes first, regardless of Provenge views.

While the data is not great for Dendreon, the firm notes that with shares trading at ~2X 2012E revenue, something much worse is priced in.

"Bottom line, we think commercial hurdles are real, but surmountable. We look for solid evidence of this before recommending full-on purchase," he said.

The firm maintained their Neutral rating and price target of $7.00.

For an analyst ratings summary and ratings history on Dendreon click here. For more ratings news on Dendreon click here.

Shares of Dendreon closed at $4.77 yesterday.

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Robert W Baird


trio.colo on 2012-08-29 15:54:24
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The data that's already out there says Provenge should pretty unquestionably go first--NeoAct abstract says 3 fold increase in multiple T-cells at the tumor rim in men treated before prostatectomy; men with psa's below 22.1 had median survival advantage of 13.1 months and then each quartile has declining survival trend as psa rises; Provenge survival advantage shows up after 6 months in all three studies, while Zytiga's only begins after 18 months and after 1/5 of men have died; Provenge can be completed in 1 month and then Zytiga can be layered on, while Zytiga first means 14 month average course of treatment with real chance after failure to no longer qualify for Pv because of pain--Provenge first means chance of getting the benefits of both, while Zytiga first may mean never getting the benefit of Pv.

tscohen on 2012-08-29 12:37:55
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One last note...a cautionary one and one doctors should note:

A paper in the Annals of Oncology suggests that treatment with abiraterone acetate may induce a loss of effectiveness of docetaxel-based chemotherapy and that men with metastatic, castration resistant prostate cancer (mCRPC) who do not respond to abiraterone acetate will also not respond to docetaxel-based chemotherapy.

The authors conclude that:

1. The activity of docetaxel given after abiraterone appears to be lower than anticipated.
2. Abiraterone-refractory patients appear to be non-responsive to docetaxel-based chemotherapy.

Clearly, more work needs to be done in this area.

tscohen on 2012-08-29 12:24:44
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Correction: the life extension benefit in the Provenge trial was seen at 6 months. I regret the omission above.

tscohen on 2012-08-29 12:21:38
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Off-label use of Zytiga in Provenge's space (NCCN Cat. 2B rating, second lowest) is interesting. In the pre-chemo Phase 3 trial recently unblinded by J&J, the data did not achieve stat sig for overall survival (one of two primary endpoints). In fact, there was no survival benefit seen in for patients in the treatment arm until the 18th month, 4 months after patients came off Zytiga (plus co-administered prednisone, of course). A life-extension benefit with Provenge (NCCN Cat. 1 rating, the highest for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer) was seen in months during he pivotal Phase 3 trial. These data argue for sequencing Provenge first if both treatments are to be given.

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