Editor's note: This article compiles the major stories that emerged over the weekend at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla. Staff Reporter Althea Chang has been providing this year's coverage for TheStreet.com and RealMoney, and she will continue to monitor events from Florida until the conclusion of the conference.
As this year's annual meeting of the American Society of Clinical Oncology approached, one company in particular seemed to be on everyone's radar --
. Investors and analysts eagerly waited to hear what the company would say about clinical trials of its colon cancer drug Avastin, which is being studied for additional applications in a bid to join the short list of drugs that successfully treat multiple maladies.
The South San Francisco, Calif., biotech company didn't disappoint. Among the numerous presentations to which Avastin was central, Genentech provided upbeat commentary on trials of the drug when used to fight breast cancer and lung cancer.
"The fact that Avastin has now demonstrated significant clinical benefits in three of the most common types of cancer
colon, breast and lung highlights how this anti-angiogenesis drug has the potential to completely change the way we treat cancer, as it could become the mainstay of treatment for a whole range of cancers," said Kathy Miller, lead investigator of an Avastin study.
For the doctors who treat cancer, the patients who fight it and the families who have lost members to it, that's the news they hoped for -- not just about Avastin, but about scores of drugs being profiled at the ASCO meeting.
Of course, Genentech was far from the only company presenting at the gathering. Among the ranks were pharmaceutical giants with tremendous product portfolios and development-stage biotech outfits still trying to get their first invention on the market.
Some came with positive data, others had to promise to keep trying. Ultimately, this year's conference offered attendees the chance to look through a window on the future -- one where successful cancer treatments provide patients and their caregivers more options from which to choose.
That said, the primary purpose of
family of Web sites is to give our readers news on the publicly traded companies behind the products presented at ASCO. With that in mind, we offer a list of companies that may see their shares move as the trading week begins.
Onyx Pharmaceuticals , working with Bayer on a drug for renal cell carcinoma;
Novartis , co-operating with Schering on a treatment for colorectal cancer;
GlaxoSmithKline , which presented data on a breast cancer product and on Bexxar in non-Hodgkin's lymphoma;
MedImmune , with data from a study involving patients with metastatic melanoma;
Cell Therapeutics , which provided a variety of results from studies of Xyotax;
Telik , a company evaluating its Telcyta in combination with chemotherapy for treating advanced non-small-cell lung cancer;
Amgen and Johnson & Johnson , with results of their products for fighting chemotherapy-induced anemia;
Pfizer , with data on the investigational drug Sutent;
Celgene , reporting on thalidomide used against multiple myeloma, and;
OSI Pharmaceuticals , which along with Genentech had results for Tarceva for advanced pancreatic cancer.
Trial findings from
for the experimental drug sorafenib confirmed interim phase III results in progression-free survival of advanced renal cell carcinoma.
As assessed by an independent review, progression-free survival was doubled to a median time of 24 weeks in patients receiving sorafenib, vs. 12 weeks for patients receiving the placebo.
Kidney cancer is resistant to most cancer drugs, but Sorafenib stopped or shrank growing tumors in trials comparing the drug and a placebo, researchers said. Sorafenib is running neck-and-neck in the race to Food and Drug Administration approval with
experimental drug Sutent. Some analysts expect Sutent to come to market under another indication in this year's fourth quarter, then gain label expansion to include kidney cancer in early 2006.
Pfizer inherited Sutent after its 2002 acquisition of Pharmacia. The product is also in trials for stomach cancer.
"We remain aggressive buyers of Onyx shares going into ASCO as we expect to see strong progression-free survival data from the phase III RCC trial," said Mark Kavorsky of Piper Jaffray in a research note before the meeting.
Based on the interim results, Bayer and Onyx plan to file for FDA approval of the treatment.
Avastin improved lung cancer survival when added to standard combination chemotherapy, according to research presented this weekend.
Avastin delayed disease progression and allowed for longer survival of non-small cell lung cancer patients, according to the research.
In a phase III trial comparing the use of paclitaxel and carboplatin, with and without Avastin, patients who received Avastin experienced cancer progression two months later and lived more than two months longer than patients who did not.
The most common side effects seen in the trial were low infection-fighting white blood cell count, blood clots and bleeding. The most significant side effect was life-threatening and even fatal bleeding from the lungs, researchers reported. This side effect occurred in 1.2% of those on Avastin, compared with none on standard chemotherapy alone. The condition was observed in 9% of patients in a previous trial.
Avastin is currently approved for colon cancer, but it's being studied as a potential treatment for other types of cancers. The drug is part of a class that stops vascular endothelial growth factor (or VEGF), a cellular substance that stimulates new blood vessel formation.
Based on solid efficacy data and low occurrence of severe side effects, "Avastin will likely gain adoption in a significant proportion of front-line patients," S.G. Cowen's health care research group wrote in a research note.
Also, according to doctors surveyed by Cowen, a safety profile that included incidence of hemoptysis, or bleeding from the lungs, of lower than 5% constitutes an acceptable safety profile.
"Although there appears to be no consensus on whether Avastin can or should be used with other first-line chemo regimens, used in second-line Avastin-naive patients, or used to treat non-centrally located squamous cell histologies, physicians expect adoption to be relatively broad with Avastin's high cost being of only minor consequence," Cowen's health care team wrote.
said a Phase III study of Avastin plus chemotherapy in first-line metastatic breast cancer met its primary endpoint of improving progression-free survival, compared with chemotherapy alone.
The companies said the results from an interim analysis of the study showed that patients receiving Avastin and paclitaxel doubled the duration of surviving without cancer progression compared with the chemotherapy paclitaxel alone (or a hazard ratio of 0.50, which is equivalent to a 50% reduction in the risk of cancer progression).
Median progression-free survival was 11 months for patients treated with Avastin plus chemotherapy, vs. six months for patients treated with chemotherapy alone.
At the interim analysis, a 49% improvement in the secondary endpoint of overall survival -- or a hazard ratio of 0.67, equaling a 33% reduction in the risk of death -- was observed.
In patients with measurable disease, the overall response rate was 28% in the Avastin plus chemotherapy arm, a doubling of the rate in the chemotherapy-alone arm.
said that data from an analysis of two Phase III studies of Herceptin in early-stage breast cancer showed that human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients receiving Herceptin plus chemotherapy had a 52% reduction in the risk of disease recurrence compared with patients who received chemotherapy alone.
After four years in the study, 15% of women treated with Herceptin and chemotherapy experienced disease recurrence, vs. 33% of women treated with chemotherapy alone.
Preliminary survival data showed a 49% improvement in overall survival, or a hazard ratio of 0.67, equivalent to a 33% reduction in the risk of death.
drug, helped advanced pancreatic cancer patients live longer, according to trial data presented this weekend.
The addition of Tarceva to gemcitabine chemotherapy improved overall survival by 23.5% compared with patients receiving the chemotherapy alone. The phase III safety and efficacy trials involved 569 patients, spanning 17 countries and 140 study centers.
Median survival for patients receiving Tarceva plus chemotherapy was 6.4 months vs. 5.9 months for those who took the gemcitabine and a placebo. Of patients who received Tarceva instead of a placebo, 72% reported a rash, compared with 29% in the placebo arm of the trial. Diarrhea was reported by 56% of patients who received Tarceva plus gemcitabine and by 41% of patients who received gemcitabine plus a placebo.
Tarceva is currently approved as a monotherapy for locally advanced or metastatic non-small cell lung cancer after at least one prior drug has failed. Two earlier clinical trials in first-line advanced NSCLC patients showed no clinical benefit when Tarceva was added to combination chemotherapy using either carboplatin and paclitaxel or gemcitabine and cisplatin.
In April, OSI submitted a supplemental new drug application with the Food and Drug Administration for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment.
Tarceva is marketed by
An experimental therapy designed to block the growth of blood and lymphatic vessels failed to show a significant improvement in progression-free survival of colorectal cancer patients, according to interim trial results presented this weekend.
An interim analysis of phase III data of the VEGF inhibitor PTK/ZK, or vatalanib, which was developed by
, failed to show a statistically significant survival benefit, researchers said.
In a trial involving 1,168 patients on Folfox chemotherapy, patients who were additionally treated with PTK/ZK didn't see a meaningful improvement in survival without disease progression. Folfox, a combination therapy, is the most common treatment for colorectal cancer.
Side effects of PTK/ZK included hypertension and thromboembolic events. Researchers said PTK/ZK didn't increase bleeding or bowel perforation when compared with a placebo. The trial is ongoing and final results are expected in the second half of 2006. In its first-quarter earnings release last month, Novartis reaffirmed its plans to submit PTK/ZK for regulatory approval in 2007.
On the positive side, the study did show that 40% of patients with a high level of LHD, an enzyme that suggests the presence of tissue damage, did show significantly improved progression-free survival.
In a press release, Novartis added that patients who received the PTK/ZK-Folfox combination had a 17% reduction in risk of disease progression, compared with Folfox alone when assessed by the patients' physicians. Assessment by central review showed a 12% reduction in risk of disease progression, however, the difference did not achieve statistical significance.
"Complete results of the study, including data on survival, will be needed to assess the overall benefit of PTK/ZK as a part of the first-line treatment of advanced colorectal cancer," said Dr. J. Randolph Hecht, the lead author of the study.
"The fact that certain specific groups of patients had greater benefit may allow us to find better ways of understanding and using these types of drugs," says Hecht.
said Zometa injection, an intravenous bisphosphonate, was shown to inhibit aromatase inhibitor-induced bone loss in postmenopausal women treated with Femara in the adjuvant breast cancer setting.
According to a press release, final data of the primary endpoint of 12-month bone mineral density demonstrated a significant increase in BMD for breast cancer patients treated with Femara and upfront Zometa compared with those who received Femara and delayed Zometa.
Several studies have shown that women treated with hormonal therapy in the adjuvant breast cancer setting are at risk of bone loss, Novartis said. New data from a Zometa-Femara study offer evidence that Zometa may prevent bone loss in these patients. The data are particularly important given that aromatase inhibitors are a widely prescribed hormonal therapy for newly diagnosed breast cancer, the company said.
investigational drug Sutent more than doubled survival and significantly reduced tumor growth and spread in a Phase III study in patients with Gleevec-resistant gastrointestinal stromal tumors, the company said.
The drugmaker said encouraging Phase II results also were observed in other tumor types, including metastatic renal cell carcinoma, metastatic breast cancer and neuroendocrine tumors, according to data presented over the weekend.
Sutent is designed to starve tumors of blood and nutrients needed for growth and simultaneously kill cancer cells that make up tumors.
The results from a Phase III study of more than 300 GIST patients resistant to or intolerant of the standard treatment Gleevec, showed Sutent prolonged the time to tumor progression (6.3 months on Sutent vs. 1.5 months for controls) and reduced the risk of death by about 50% compared with a placebo, Pfizer said in a press release.
In addition, long-term follow-up data from the Phase I/II GIST study demonstrated that Sutent extended overall survival to nearly 20 months in patients whose cancer had progressed despite treatment with other standard therapies. Also, the median time to tumor progression in this study was 7.8 months for all patients, with some patients benefiting even more.
Gleevec is made by
Separate data were released from two Phase II studies of patients with resistant renal cell, or kidney, tumors. In a 63-patient trial, 40% of patients responded to treatment with Sutent. Tumors didn't progress for more than three months in an additional 28% of patients, indicating that 68% of patients benefited from the treatment, Pfizer said. The average time to tumor progression for patients in this study was 8.7 months, and the median overall survival was 16.4 months.
A second Phase II study of 106 patients demonstrated an objective response rate of 39% in patients treated with Sutent, the company said. Among the patients, 23% saw tumor stabilization. Taken together, a total of 62% of patients benefited from treatment with Sutent, Pfizer said.
said the preliminary data from a study involving patients with stage IV metastatic melanoma showed a 12.7-month median survival for those treated with Vitaxin alone.
Data also showed a 9.4-month median survival for patients treated with Vitaxin plus dacarbazine (DTIC). In a separate recent Phase III trial, patients treated with DTIC alone -- the current standard of care in advanced melanoma -- had a median survival of 7.9 months, the company said.
Vitaxin is MedImmune's development-stage monoclonal antibody being evaluated in separate trials involving patients with advanced melanoma and prostate cancers.
The preliminary data demonstrated that the one-year survival rate was 53% for patients receiving Vitaxin alone, while the one-year survival rate was 42% for patients receiving Vitaxin plus DTIC. Data on three patients are still pending.
In the study, 112 patients with stage IV metastatic melanoma received weekly intravenous infusions of Vitaxin either alone or in conjunction with DTIC once every three weeks. To date, safety data suggest that Vitaxin has been generally well tolerated in these patients. Immunogenecity data are pending.