How will ASCO 2012 change the future of cancer?
7 May 2012, by Gordon Gochenauer
The outgoing president of the American Society of Clinical Oncology (ASCO), George Sledge, declared 2011 to be the “Year of Melanoma” during the plenary session at the ASCO Annual Meeting June 1-5, 2011. This was a reaction to the back-to-back presentations of the Phase III trials for Yervoy™ (ipilimumab, Bristol-Myers Squibb) and Zelboraf® (vemurafenib, Roche/Daiichi-Sankyo) for first-line melanoma patients.
Perhaps 2012 could be the “Year of Many Cancers.” This blog highlights nine key Phase III trials that are known to or strongly believed to have hit their primary endpoints (though there are many more Phase I and Phase II success stories not included below). A broader discussion of each trial is available here. These trials will affect a wide array of cancer types and will likely lead to broadening the labels of currently approved agents such as Zytiga® (abiraterone, Johnson & Johnson) and Avastin® (bevacizumab, Roche) and regulatory approvals for the remainder.
| Kantar Health’s Top Presentations of Interest, ASCO 2012 |
| Agent | Indication | Abstract | Date and Time |
| Zytiga | CRPC, chemotherapy-naive | LBA4518 | June 2, 8:00 am |
| Tivozanib | RCC, first-/second-line | 4501 | June 2, 3:15 pm |
| Avastin | Ovarian Cancer, platinum-resistant, recurrent | LBA5002 | June 2, 3:30 pm |
| Avastin | CRC, second-line | CRA3503 | June 3, 10:45 am |
| T-DM1 | HER2+ Breast Cancer, refractory | LBA1 | June 3, 1:45 pm |
| Dabrafenib | Melanoma, first-line, B-RAF mutants | LBA8500 | June 3, 8:00 am |
| Trametinib | Melanoma, first-line, B-RAF mutants | LBA8509 | June 4, 3:15 pm |
| Cabozantinib | Thyroid Cancer, Medullary | 5508 | June 4, 11:30 am |
| Afatinib | NSCLC, first-line, EGFR mutant | LBA7500 | June 4, 3:00 pm |
The Phase III trial for tivozanib (Aveo/Astellas) has been highly speculated about. Many in the market were underwhelmed by the top-line results announced by the companies in early January 2012. With many agents already on the market for renal cell carcinoma (RCC), as I previously discussed here, this trial will be highly scrutinized to verify that tivozanib is truly one of the most active and safest VEGFR tyrosine kinase inhibitors, distinguishing its value proposition over the other agents approved for RCC.
I still believe 2012 can be another “Year of Melanoma.” Another B-RAF inhibitor, dabrafenib (GlaxoSmithKline), will show positive results in the plenary session from its Phase III trial for melanoma patients with a B-RAF mutation. More interesting might be a separate clinical science symposium titled “Mutated Melanoma: The Role for MEK inhibitors” on Monday, June 4, where positive Phase III trial data from GSK’s MEK inhibitor, trametinib, also in B-RAF mutated melanoma, will be presented. A Phase I/II trial combining both agents will be presented in the same sessions. The combination of B-RAF and MEK inhibitors are hoped to be superior to either one since it is believed that the MEK pathway may be a mechanism of resistance to B-RAF inhibitors. Phase I data from Novartis’ MEK inhibitor, MEK162, will also be presented in B-RAF mutated melanoma. Data from several other MEK inhibitors and PI3K inhibitors previously mentioned here will also be presented at ASCO 2012.
These two storylines are of most interest for me. Perhaps most importantly, I am excited for ASCO 2012. The conference will be highlighted by successes for manufacturers, researchers and patients. Prior to ASCO 2010, it was difficult to find more than a handful of Phase III successes. This year we can expect a meeting that is just as exciting as 2010 and 2011. See you in June!
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oncology, gochenauer, RCC, Melanoma, Ovarian Cancer, Thyroid Cancer, Cancer, HER2+ Breast Cancer, CRC, ASCO 2012, CRPC
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