The immunotherapy trend continued, which included positive results of already marketed CTLA-4 and PD-1 inhibitors, Bristol Myer-Squibb's Yervoy and Opdivo, Merck's Keytruda in new oncology indications, Roche/Genentech's PD-L1 inhibitor Tecentriq and Juno Therapeutic and Kite Pharma's CAR T-cell therapies.
Other key indication findings from the 2016 ASCO Meeting include:
- Multiple Myeloma: Interim results from the Phase III CASTOR trial in relapsed refractory multiple myeloma whereby the addition of Darzalex to Velcade (and dexamethasone) improved progression-free survival (60.7 percent) versus Velcade (and dexamethasone) alone (26.9 percent) (i.e., a 61 percent reduction in the risk of progression). While this improvement is unprecedented and likely to translate into overall survival benefit, questions were raised over the financial burden of the addition of Darzalex.
- Breast Cancer: Extending aromatase inhibitor therapy from five to ten years in patients with postmenopausal HR-positive breast cancer improves disease free survival compared with placebo (95 percent vs 91 percent, respectively), according to Phase III (MA.17R) data presented at the conference.. While five years of aromatase inhibitor therapy treatment with/without tamoxifen is standard practice in this indication, there has never been any data to support this.
- Acute Myeloid Leukemia: Elderly patients (≥60 years of age) with high-risk acute myeloid leukemia have significantly worse prognosis than those diagnosed with de novo disease. Phase III data in this poor prognostic group reveals that Vyxeos, a liposomal formulation of standard treatment, cytarabine and daunorubicin, achieves a significant 3.61 month survival advantage over standard treatment. At the ASCO meeting, oncologists called for Vyxeos to be considered the standard first-line treatment for elderly patients with high-risk acute myeloid leukemia.
- Colorectal Cancer: There has been an explosion in the number of immune checkpoint inhibitor studies in metastatic colorectal cancer. Interim data from the Phase I/II Checkmate-142 trial showing that Opdivo and Opdivo plus Yervoy induced impressive overall response rates of 25.5 percent and 33.3 percent, respectively. Other data presented from a Phase Ib study assessing Tecentriq in combination with MEK inhibitor, Cotellic, demonstrating an overall response rate of 17 percent in all microsatellite-stable patients; data were slightly higher in tumors harboring KRAS mutation (20 percent).
- Bladder Cancer: Tecentriq, the first PD-L1 inhibitor to reach the market (May 2016), is the newest addition to bladder cancer armamentarium. Tecentriq is approved as a second-line treatment, but according to Phase II (IMvigor210) data presented at ASCO, it's also effective as a first-line therapy. Tecentriq achieved a remarkable median overall survival of 14.8 months; overall survival is typically nine to ten months with carboplatin-based regimens.
Insights from Decision Resources Group Analysts:
- "Immune checkpoint inhibitors are poised to not only benefit patients with microsatellite instability-high colorectal cancer but also select patients with microsatellite-stable disease, originally thought to be unresponsive to these agents. Combinatory approaches of immune checkpoint inhibitors and targeted therapies are most likely to emerge as key players in the future treatment of colorectal cancer." – Steven Tinsley BSc (Hons), MSc, Ph.D.
- "The development of new therapies for oncology indications has opened up many new opportunities to treat patients. However, the high-cost of some of these therapies – notably the immunotherapies which have performed well in several indications – poses new questions about how to best allocate resources without straining healthcare systems or individuals." – Sehrish Rafique, M.Sc., Ph.D.
- ''Juno and Kite's ambition to bring their CAR T-cell therapies to market in 2017 is on track. The results are jaw-dropping. We are seeing the majority of acute lymphoblastic leukemia patients going into remission and responses appear durable. I have no doubt that these therapies are going to be the next breakthrough in oncology.'' – Michalina Jenkins BSc (Hons), M.Sc., Ph.D.
Additional resources from Decision Resources Group:
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SOURCE Decision Resources Group