NEW YORK, May 13, 2014—Kantar Health, a leading global healthcare consulting firm, has identified the top abstracts expected to generate the most interest at the annual meeting of the American Society of Clinical Oncology (ASCO). The 2014 meeting promises to be packed with the latest data and trends in oncology. Among the 5,000 abstracts submitted by clinical researchers from around the world, abstracts from two Phase III and one Phase II studies are likely to generate the most discussion and have the potential for high impact in the short term.
Imbruvica versus Arzerra in Relapsed/Refractory CLL
Both Imbruvica™ (ibrutinib, Pharmacyclics/Johnson & Johnson) and idelalisib (Gilead) are generating a lot of excitement as potential treatment options in non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Arzerra® (ofatumumab, Genmab/GlaxoSmithKline) is currently approved for use in refractory CLL patients in both the United States and Europe. Imbruvica has already garnered accelerated approvals as a monotherapy for both mantle cell lymphoma and CLL based on Phase II data. While work on these two applications were ongoing with the FDA, Pharmacyclics initiated a Phase III trial (RESONATE) that compares Imbruvica versus Arzerra.
The data from this trial will be closely monitored. How much difference will there be in these efficacy endpoints for Imbruvica and Arzerra? Although physicians have been equally excited about both idelalisib and Imbruvica, they will look closely at the efficacy data from RESONATE to help guide them as they select which agent to use or in which patient subtype to offer a particular agent.
In the same session, long-term follow-up data from the Phase Ib/II trial for Imbruvica will be presented (Abstract 7014) prior to the data release for RESONATE. As this data for Imbruvica is released and will hopefully be followed by similar data for idelalisib, these long-term data will become more important. Can Imbruvica and idelalisib be given long-term, and if so, are there any cumulative toxicity issues of note? Are there biomarkers that may identify patients who are more likely to respond more favorably to either agent? Abstract LBA7008, Tuesday, June 3, 11:57 AM
CALGB 80405: Will This Definitively Determine the Appropriate Sequence of Targeted Therapies in Metastatic CRC?
Both Avastin® (bevacizumab, Genentech/Roche/Chugai) and Erbitux® (cetuximab, Bristol-Myers Squibb/Eli Lilly/Merck KGaA) are approved for the treatment of first-line metastatic colorectal cancer (mCRC) and have demonstrated progression-free survival (PFS) and overall survival (OS) benefits when added to standard chemotherapy in these patients; however, Erbitux is approved for use only in the subgroup of patients with wildtype KRAS. As with all new therapies that enter the same indication, physicians are left wondering how best to incorporate these agents into their practices. As multiple Phase III trials showed combining the agents are not effective, two trials set out to evaluate the sequence that these agents should be offered to patients.
Currently, U.S. physicians strongly favor Avastin-based regimens in first-line over Erbitux-based regimens in patients with KRAS wildtype mCRC, according to Kantar Health’s CancerMPact® Treatment Architecture data. This is largely based on order of entry, with Avastin receiving a first-line FDA approval eight years before Erbitux. Western European physicians slightly favor Erbitux-based regimens in first-line over Avastin-based regimens in patients with KRAS wildtype mCRC. This may be based on a preference for biomarker-driven treatment selection, which Erbitux affords. Both are also influenced by a lack of data to understand whether one of these agents is superior to the other. Since questions remain after the results of FIRE-3, the results of CALGB 80405 will ultimately be cited in comparisons between the two agents. Should the results of CALGB 80405 favor Avastin or show no significant difference between the two regimens, Kantar Health anticipates little impact on the current market. Abstract LBA3, Sunday, June 1, 2:45 PM
Pembrolizumab (formerly lambrolizumab) in Relapsed/Refractory Advanced Melanoma
The past several years have seen an explosion of new agents for the treatment of advanced melanoma: Yervoy® (ipilimumab, Bristol-Myers Squibb), Zelboraf® (vemurafenib, Genentech/Roche/Daiichi Sankyo), Tafinlar® (dabrafenib, GlaxoSmithKline) and Mekinist® (trametinib, GlaxoSmithKline). Moreover, other agents are waiting in the wings, as past ASCO meetings have highlighted the promise of Bristol-Myers Squibb’s anti-PD-1 monoclonal antibody nivolumab. However, at ASCO 2014 another anti-PD-1 monoclonal antibody, pembrolizumab (lambrolizumab, MK3475, Merck), will take center stage.
As Bristol-Myers Squibb initiated Phase III trials for nivolumab in December 2012 (for relapsed melanoma) and January 2013 (for first-line melanoma), it appeared that this agent would be the first to market. However, Merck filed for accelerated approval of pembrolizumab and announced on May 6 that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for pembrolizumab for review, for treatment of unresectable or metastatic melanoma in patients previously treated with Yervoy. The FDA granted Merck Priority Review status for pembrolizumab with a PDUFA of October 28, 2014.
Given the high level of competition as mentioned above, it will be important to compare the efficacies and toxicity profiles of the PD-1 checkpoint inhibitors. Kantar Health believes that pembrolizumab will show a benefit compared to the control arm and therefore should be strong enough to support Merck’s efforts to be first to market.
The primary question for pembrolizumab in this Phase II trial, therefore, will be efficacy as this will be a guide in assessing pembrolizumab’s further prospects in other melanoma settings. Will it be strong enough to offer hope against front-line Yervoy and, in the future, nivolumab? Abstract LBA9000, Monday, June 2, 3:00 PM
Kantar Health identified a total of 10 abstracts that are expected to be presented at ASCO that will generate significant interest. The full list can be found in the most recent issue of Oncology Business Review.
About Kantar Health
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