Bayer's regorafenib delays stomach cancer in last-ditch study
Bayer has taken another step forward in its quest to make regorafenib into a blockbuster drug, offering new late-stage data which show the drug put the brakes on stomach cancer among a group of patients who had failed two standards of care. The median progression-free survival time for the regorafenib arm of the study was 4.8 months compared to only 0.9 months in the placebo arm. The study did not demonstrate added overall survival time.
"We do believe that this is very important data," Dirk Laurent, head of global clinical development for Bayer, tells FierceBiotech. All the patients in the study had been heavily pretreated with Gleevec and Sutent, with no remaining options.
For Bayer, which has had only one big cancer drug--Nexavar--on the market, the regorafenib data represents a major success in its long campaign to create a cancer franchise. Company execs at ASCO reiterated that the drug can emerge as a blockbuster if it goes on to win approval for several cancers. Regorafenib has already been filed for metastatic colorectal cancer and the company says it will now file for gastrointestinal stromal tumors in the second half of this year.
The news is also a plus for Onyx Pharmaceuticals ($ONXX), which wrested a 20% royalty stream on the drug after learning how closely regorafenib resembles Nexavar.
- here's the press release
Zytiga impresses in prostate cancer
Johnson & Johnson ($JNJ) was out early in the ASCO meeting with data demonstrating some impressive results among pre-chemo prostate cancer patients. Already approved in the post-chemo crowd, investigators said that patients in the control arm achieved an average progression-free survival rate of 8.3 months while investigators had yet to establish PFS for the Zytiga arm as their cancer was progressing more slowly.
J&J stopped its study early--and with great fanfare--so that the steroid-only arm of the study could get Zytiga. As a result, the stats fell shy of statistical significance on overall survival, a fact that the pro-Provenge crowd at ASCO jumped on. But J&J is confident that it has the data needed to expand the label to include a much larger population of patients. Investigators estimated a 33% improvement in overall survival for the drug arm.
"These results are very promising for abiraterone acetate in the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic and have not received chemotherapy. The results also advance our understanding of the role of androgen biosynthesis inhibition in this patient population," said Charles J. Ryan, M.D., lead investigator of the study.
J&J's team says that the company will file for expanded approval in the second half of this year. And given the way cancer meds are prescribed, where more than half of all scrips are provided off-label, a shift in the market is likely already underway.
That all amounts to more bad news for Provenge, which has suffered by comparison with Zytiga. Medivation, meanwhile, has its own prostate cancer pill in studies. And the company used ASCO to highlight some new secondary endpoint data demonstrating that enzalutamide (formerly MDV3100) improved quality of life and delayed the time to first skeletal-related events in men with a castration-resistant form of the disease. The Medivation drug appears well positioned and is a favorite with some analysts who have been deeply impressed with the drug's efficacy profile.
- here's the press release
Aveo makes a PhIII case for tivozanib, plots head-to-head with Sutent
Aveo CEO Tuan Ha-Ngoc and CMO Bill Slichenmyer were in Chicago to raise the flag for tivozanib, a new drug slated to head to the FDA in the near future in search of an approval for kidney cancer. Aveo put its best foot forward in advance of ASCO, highlighting data that demonstrated a better safety profile and tolerability compared to Nexavar. And Monday morning the company announced that it is planning a head-to-head study with Sutent as it positions the drug against heavy competition.
Aveo ($AVEO) has already posted a significant, though overall modest, edge over Nexavar on efficacy. And headed into a crowded market with its first prospective commercial launch, the biotech will work overtime to avoid some of the pitfalls that have befallen other companies which transitioned to commercial operations.
Investigators for Aveo and its partner Astellas will now recruit 160 patients for the head-to-head with Sutent. "The primary objective of the study," the company says, "is to compare patient preference after receiving both tivozanib and sunitinib in sequence. Secondary objectives are to evaluate the incidence of treatment-emergent Grade 3/4 adverse events and serious adverse events; frequency of dose modifications; and quality of life in patients treated with tivozanib versus sunitinib."
The CEO says he was encouraged by the T-DM1 presentation, which also focused on the quality of life of patients. "This is the theme and future of cancer," Ha-Ngoc tells FierceBiotech, making the case that the single daily pill was easier for patients to take, triggering far fewer instances where doctors were required to reduce dosage compared to sorafenib. Given the totality of the efficacy, safety and tolerability presentation, Slichenmyer says he feels confident that Aveo can offer a convincing case to regulators.
Failure is not an option. Aveo is already ramping up its sales efforts in anticipation of debuting the drug next year. Aveo and Astellas are partnered on the drug, with Aveo taking the lead in the U.S. market and Astellas taking the lead role in Europe.
- here's the press release on the trial announcement
Seattle Genetics expands its CD-30 horizons
"You can't do drug development in quarters," says Clay Siegall, the effusive chief at Seattle Genetics ($SGEN).
That's what he tells himself when his company's stock dips every time the revenue numbers at Seattle Genetics don't jibe with Wall Street's expectations--as it did, momentarily, just days ago.
So it's steady as he goes at the tiller of Seattle Genetics, which has two approvals for Adcetris and bragging rights for a stream of antibody-drug conjugate technology deals with Genentech and the like.
Adcetris is an ADC which is aimed right at CD-30 positive malignancies, a targeted approach that has broad applicability across a range of cancer types. Not only does the biotech have its own studies under way, a number of academics have been carrying out CD-30 investigations of their own. And the company plans to steadily chip away at new indications.
At ASCO, Siegall was manning the big company exhibit, happy to chat about new data. In a Phase II study, 70% of evaluable patients who had started treatment with Adcetris and then discontinued therapy achieved an objective response to their disease after restarting therapy. And in a separate mid-stage study of patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, a third of the 14 evaluable patients achieved an objective response, including two complete responses and two partial responses.
- here's the press release