The last 18 months have seen a lot of failed cancer studies in phase III development after early promising phase II results, teaching us that sometimes rushing full steam ahead without fully understanding the issues is not always the smartest strategy.
Let's start with Pfizer's figitumumab, an IGF-1R antibody, which we have previously discussed in non-small cell lung cancer (NSCLC) (here and here). There was one phase II trial at MD Anderson that led to what many of us thought was a rather cavalier, aggressive and hasty phase III program, without really seeking to understand the underlying biology behind the pathway first. Interestingly, other competitors have taken a much slower and more methodical approach to thinking through the various issues and may well come out ahead as a result.
This is a preview of More phase III cancer trials flop: Pfizer (Sutent) and Roche (Avastin). Read the full post
Last night many people in the NY-NJ-CT region missed the Oscars beamed from the Academy Awards after an argument over money between CableVision and ABC. If a Biotech company and their big Pharma partner has a spat, it is rarely as public or has as much impact as TV deals do, but the shock waves can certainly be felt through the investor community every time a high profile predatory shareholder such as Carl Icahn gets their teeth into a biotech such as Genzyme or Biogen IDEC.
After yesterday's news regarding the negative data for bevacizumab (Avastin) in gastric cancer, I wasn't expecting to hear any more from Roche this week, however, the opposite happened and this morning positive data was sitting waiting for me in my inbox today!
Well, results from phase III study demonstrated the combination of bevacizumab and chemotherapy followed by maintenance use of bevacizumab increased the time women with advanced ovarian cancer lived without their disease worsening as measured by progression-free survival (PFS) compared to chemotherapy alone. Advanced ovarian cancer generally has a poor prognosis, so new therapy options are much needed.
This is a preview of Roche on a roll with positive data for Avastin in ovarian cancer. Read the full post
Things were so busy in the Icarus office yesterday I didn't get a moment to post on the Roche/Genentech news that the latest topline phase III trial analysis for bevacizumab (Avastin) were disappointing. The company announced the findings in a press release:
"Avastin (bevacizumab) in combination with Xeloda (capecitabine) or fluorouracil and cisplatin chemotherapy in patients with inoperable, advanced or metastatic gastric cancer (stomach cancer). The study, known as AVAGAST, did not meet its primary endpoint of extending overall survival in patients treated with Avastin in combination with chemotherapy compared to the same chemotherapy plus placebo."
This snippet from Reuters posted earlier this week while I was listening to the Roche earnings call in Basle, which was a nicely put together presentation:
"Roche Holding AG overhauled the sales efforts for its best-selling drug, the Avastin cancer treatment, after the company “lost steam” during the fourth quarter.
Sales of the medicine were hurt by a focus on selling it as a treatment for breast tumors, Pascal Soriot, the head of the pharmaceuticals division, said in an interview today. The company beefed up marketing by assigning the sales team responsible for the Herceptin breast cancer drug to also promote Avastin, while the group that sells the Xeloda therapy will promote it for use against colorectal cancer, he said.
This is a preview of Why did Roche's Avastin lose steam in 4th quarter 2009?. Read the full post
After writing the first two posts in the series, I was much amused to see this tweet in my Twitter stream from one of buddies:
When you've been blogging on science, marketing, PR and cancer topics for several years you begin to wonder if it actually beneficial to anyone, so today's post is dedicated to Miguel in Barcelona for making me smile :-). If you're on Twitter, please do follow him because he's a great guy and shares a lot of very interesting pharma related links. Give him some Twitter love!
Amgen's recent announcement of phase III trial data showing that it's monoclonal antibody, denosumab was superior to Novartis' Zometa (zoledronic acid) for the treatment of breast cancer patients with bone mestastases is further news that scientifically driven drug development can yield exciting results.
Denosumab is in essence a targeted therapy like Gleevec, Avastin or Herceptin. It's development came about from basic research that discovered the cellular control of bone remodelling and regulation of bone density is reglated by the RANK Ligand pathway.
This is a preview of Clinical trial results show Denosumab is superior to Zometa in breast cancer patients with bone metastases. Read the full post
The American Cancer Society estimates 183,000 new cases of breast
cancer will be diagnosed in the United States this year with more than
40,000 dying from the disease. A portion of these are women who have triple negative breast cancer, which confers a poorer prognosis.
Triple negative breast cancer occurs where the tumour does not express
estrogen (ER) or progesterone (PR) receptors or HER2 protein. This means that standard
treatment with hormone blocking agents and agents that target HER2
such as tamoxifen and Herceptin respectively, are ineffective weapons against this subtype of breast
cancer. Women with triple negative breast cancer generally have shorter survival than those who are ER/PR positive. Identifying better combinations of chemotherapy
and novel biologic agents that are effective in this disease is
Eli Lilly’s Alimta (pemetrexed) slowed the spread of non-small cell lung cancer in patients with advanced disease. It’s approved for use in patients who have failed chemotherapy; this study suggests it may be added to treatment earlier in the course of disease. Lilly are reportedly filing the early data in patients with select histology later this year. It was recently approved for first-line use in the EU.