Global Insight Perspective | |
Significance | ASCO is among the most important events in the pharma—particularly biotech—calendar, as a wide range of companies provide first or detailed insight into their candidates in the field of cancer. |
Implications | Traditionally, ASCO provides a vital setting for dominant oncology players such as Genentech (U.S.), GlaxoSmithKline (GSK; U.K.) and Bristol-Myers Squibb (BMS; U.S.), but this year's conference looks like a more level playing field, with important milestones for a number of therapeutic cancer areas. |
Outlook | ASCO 2007 looks set to be transformational in the areas of liver cancer (Sutent, Nexavar); lung cancer (Avastin); melanoma (CTLA-4 antibodies); colorectal cancer (Erbitux); breast cancer (Tykerb); and myeloma (Revlimid, Velcade). |
ASCOing the Right Questions
A vast number of pharmaceutical and biotech companies will unveil their latest clinical data at the annual gathering of the American Society of Clinical Oncology (ASCO). The meeting provides a vital forum to gain contact with clinical physicians and arrest media attention for promising clinical candidates or new data for already approved drugs. There is usually some volatility in valuations of oncology companies around this time, although these tend to subsequently pan out over the remainder of the year as the market more fully absorbs the impact of the data.
Again, most focus will be on the “big four” therapeutic areas of colorectal, breast, lung and prostate cancers. Some of the high-profile “old school” cancer drugs will again have a prominent role at ASCO, with Genentech/Roche’s (U.S./Switzerland) Herceptin (trastuzumab) and Avastin (bevacizumab) together featuring in a total of 77 presentations. However, although these are still fully branded, fast-growing franchises, ASCO will also increase visibility in non-generic competitors to these drugs, particularly in colorectal cancer, where BMS/ImClone’s Erbitux (cetuxumab) will reveal its CRYSTAL data in front-line disease—currently it is used in combination with Pfizer’s Camptosar (irinotecan) or as a monotherapy in refractory colorectal cancer. With compelling data, it can break Avastin’s surge in this market. In breast cancer, meanwhile, GlaxoSmithKline (GSK; U.S.) is already building up expectations for its newly approved Tykerb (lapatinib), which is used in combination with Roche’s Xeloda (capecitabine) in Herceptin-refractory patients. Herceptin’s de facto monopoly position here is clearly under threat.
Elsewhere, Pfizer and Bayer Schering/Onyx are expected to release data for TK inhibitors Sutent (sunitinib) and Nexavar (sorafenib) respectively. Having been on the market for a year and a half, these drugs are jostling for the leading position in liver cancer. Nexavar is due to reveal its full Phase III SHARP data, potentially resulting in it taking the lead, which Sutent appears to have stolen in this space; comparative clinical and commercial use is hitherto difficult to ascertain due to Onyx’s disclosure policy. Still, Pfizer may counter with some Sutent presentations of its own, particularly its Phase II response rate data. These two sets of rival data are both being presented on Monday (4 June).
On the new product front, Global Insight is particularly looking out for Bristol-Myers Squib’s (BMS; U.S) ixabepilone in breast cancer; Spectrum/GPC’s satraplatin in prostate cancer; Pfizer’s anti-CTLA-4 antibody ticiliumumab; Regeneron/Sanofi-Aventis’s VEGF Trap in ovarian cancer and NSCLC; Pfizer’s axitinib in breast and non-small cell lung cancers; GSK’s pazopanib in ovarian cancer; and Astellas’s survivin suppressant YM-155 in prostate cancer. Elsewhere, Merck & Co (U.S.) is also providing brain cancer data on its newly approved, first-in-class HDAC inhibitor Zolinza (vorinostat).
Outlook and Implications
ASCO plays an important role in validating not only the clinical potential of the presented drugs, but also the class they represent. Thus, companies engaged in new classes such as HDAC inhibitors (Gloucester, Topotarget) and CTLA-4 antibodies (Medarex) will be paying close attention to events at the meeting, and their valuations will fluctuate according to the data released. The anaemia space (Amgen, Johnson & Johnson, Roche) has been heavily hit by the recent regulatory clampdown in oncology, and will likely be a relatively quiet field at the meeting. Please see below for the presentations that Global Insight believes have the biggest catalyst potential.
Key Presentations: ASCO 2007 | |||
Drug | Company | Title | Day |
Breast Cancer | |||
Axitinib | Pfizer | A randomised, double-blind Phase II study of the oral TK inhibitor axatinib in combination with docetaxel compared with DOC plus placebo in metastatic breast cancer. | Saturday |
Herceptin / Omnitarg | Genentech | Objective response rate in a Phase II trial of pertuzumab in combination with Herceptin in patients with HER2 metastatic breast cancer which has progressed during treatment | Saturday |
A report of cardiac events in a Phase II clinical study using Herceptin with Omnitarg in HER2 advanced breast cancer. | |||
Herceptin / Tykerb | Genentech/GSK | EGF105084, a Phase II study of lapatinib for brain metastases in patients with HER2 breast cancer following Herceptin-based systemic therapy and cranial radiotherapy. | Sunday |
Ixabepilone | BMS | Phase III trial of ixabepilone plus Xeldoda compared with Xeloda alone in patients with advanced breast cancer previously treated or resistant to an anthracycline and resistant to taxanes. | Sunday |
Tykerb | GSK | Tykerb with paclitaxel compared with paclitaxel as first-line treatment for patients with advanced breast cancer; a randomised, double-blind study of 580 patients. | Sunday |
CNS | |||
Cerdiranib | AstraZeneca | A Phase II trial of AZD-2171 in patients with recurrent glioblastoma. | Monday |
Cilengitide | Merck Serono | Phase IIa trial of cilengitide as single-agent therapy in patients with recurrent glioblastoma. | Monday |
Vorinostat | Merck & Co | N047B: NCCTG phase II trial of vorinostat in recurrent glioblastoma multiforme. | Sunday |
Colorectal Cancer | |||
Avastin | Genentech | Association between exposure to Avastin beyond first progression and overall survival in patients with mCRC. | Saturday |
Avastin | Genentech | Serious arterial thromboembolic events in patients with mCRC with AVastin; BRiTE. | Monday |
CP-675,206 | Pfizer | A Phase II study of the anti-CTLA4 mAb in patients with refractory metastatic adenocarcinoma of the colon or rectum. | Sunday |
Erbitux | Imclone, BMS | Randomised Phase III study of Camptosar and 5-FU/FA with or without Erbitux in first-line treatment of mCRC; CRYSTAL. | Tuesday |
PTK-787 | Novartis | Final results of CONFIRM2; Multinational, randomised, double-blind Phase III study in second-line patients with mCRC receiving FOLFOX4 and PTK787 or placebo. | Saturday |
Head & Neck / Thyroid Cancer | |||
Axitinib | Pfizer | A Phase II study of axitinib in patients with advanced thyroid cancer. | Saturday |
Nexavar | Onyx, Bayer Schering | A Phase II trial of Nexavar in patients with recurrent and/or metastatic H&N squamous cell carcinoma. | Monday |
Tarceva | OSI, Genentech, Roche | Final results of Phase II study of Tarceva, docetaxel and cisplatin in patients with recurrent/metastatic H&N cancer. | Saturday |
Renal Cell Carcinoma | |||
Cerdiranib | AstraZeneca | Phase II study of AZD-2171 in first-line progressive, unresectable, advanced mRCC. | Sunday |
Nexavar | Onyx, Bayer Schering | Final results of randomised Phase III trial of Nexavar in advancedrenal cell carcinoma; survival and biomarker analysis. | Sunday |
Sutent | Pfizer | Phase II trial of Sutent in Avastin-refractory mRCC. | Saturday |
Leukaemia | |||
Campath | Genzyme | Impact of prognostic factors on outcome in a Phase III study comparing Campath to chlorambucil as first-line therapy for BCLL. | Monday |
Nilotinib | Novartis | A Phase II study of nilotinib administered to Gleevec-resistant and intolerant patients with chronic or accelerated CML. | Saturday (chronic); Monday (accelerated) |
Liver Cancer | |||
Nexavar | Onyx, Bayer Schering | Nexavar improves survival in advanced HCC; results of a Phase III randomised placebo-controlled trial (SHARP). | Monday |
Sutent | Pfizer | A Phase II study of Sutent in patients with advanced HCC. | Monday |
Lung Cancer | |||
Avastin | Genentech | Final analysis of multi-centre, double-blind, placebo-controlled, randomized Phase II trial of Gemzar/cisplatin plus Avastin or placebo in patients with malignant mesothelioma | Sunday |
Randomised double-blind multicentre Phase III study of Avastin in combination with cisplatin and Gemzar in chemotherapy-naïve patients with adanced or recurrent non-squamous NSCLC. | Saturday | ||
Axitinib | Pfizer | Efficacy of axatinib in patients with advanced NSCLC in Phase II. | Saturday |
Erbitux / Velcade | ImClone, BMS / Millennium | Phase II randomised trial of docetaxel plus Erbitux or bortezomibn in patients with advanced NSCLC. | Monday |
Erbitux | ImClone, BMS | Phase II study of Erbitux in combination with carboplatin and docetaxel for patients with advanced/metastatic NSCLC. | Sunday |
Vandetanib | AstraZeneca | Randomised Phase II study of vandetanib alone or with carboplatin and paclitaxel as first-line treatment for advanced NSCLC. | Saturday |
VEGF-Trap | Regeneron, sanofi-aventis | Phase II study of the efficacy and safety of VEGF-Trap given every two weeks in patients with platinum- and Tarceva-resistant adenocarcinoma of the lung. | Sunday |
Multiple Myeloma | |||
Revlimid | Celgene | Phase III trial of lenalomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma (E4A03). | Sunday |
Velcade | Millennium | Final results of a Phase II PETHEMA trial of alternating Velcade and dexamethasone as induction regimen prior ASCT in younger patients with multiple myeloma; efficacy and clinical implications of tumour response. | Sunday |
Ovarian Cancer | |||
Pazopanib | GSK | Pazopanib is active in women with advanced epithelial ovarian, fallopian tube and peritoneal cancers; initial results of a Phase II study. | Saturday |
VEGF-Trap | Regeneron, sanofi-aventis | VEGF-Trap for patients with recurrent platinum-resistant epithelial ovarian cancer; preliminary results of randomised, multicentre Phase II study. | Sunday |
Pancreatic Cancer | |||
Erbitux | ImClone, BMS | Phase II trial for advanced pancreatic cancer with randomisation between Camptosar/docetaxel and Camptosar/docetaxel plus C225. | Saturday |
Phase III study of GEmzar plus Erbitux versus Gemzar in patients with locally advanced or metastatic pancreatic adenocarcinoma. | Sunday | ||
Gemzar / Avastin | Lilly / Genentech | A double-blind, placebo-controlled randomised Phase III trial of Gemzar plus Avastin versus Gemzar plus placebo in patients with advanced pancreatic cancer; preliminary analysis of CALGB. | Sunday |
Prostate Cancer | |||
Satraplatin | Spectrum / GPC | Satraplatin demonstrates significant clinical benefits for the treatment of patients with HRPC; results of a randomised Phase III trial. | Monday |
YM-155 | Astellas | Phase II monotherapy study of YM-155 administered by 168-hour continuous infusion in previously treated HRPC. | Sunday |
Source: Global Insight | |||