ASCO is the largest annual gathering of the worldwide oncology community, and this year’s event takes place this coming weekend, from June 2-6 in Chicago, Illinois. About 10 days ago, the association released its program and a wide slate of abstracts that have given way to plenty of media reports and speculation about what other news may emerge from the meeting itself. Here are just a few highlights that we will be watching with interest…
This year’s theme is “Making a Difference in Cancer Care with You.” ASCO’s intent is to demonstrate their commitment to providing the latest science and education around cancer care. Featured sessions will also focus on the way that the cancer community cares for patients, including the role of the multi-disciplinary team in cancer care and the active engagement of patients and the community through social media, mobile technology and other tools for aiding education, clinical trial recruitment and research. ASCO is placing a high emphasis this year on education and overcoming barriers to quality care and research. We find this interesting, and a reflection of the increasing complexity in cancer care as a result of new treatment options, the need for biomarker testing, a growing desire to increase patient centricity in cancer trials as well as overall patient care, and the continued debate around pricing.
Another big emphasis this year is on combination therapies, not only in immuno-oncology, but also with targeted therapies. Several upcoming presentations have attracted particular attention, such as the data from Merck’s KEYNOTE-021 study in patients with previously untreated metastatic non-small cell lung cancer (NSCLC), which reported at overall response rate of 57% for the combination of Keytruda plus chemotherapy versus 30% for chemo alone. At a median follow-up of 14.5 months, Merck is also reporting a 31% reduction in the risk of death for the combo versus chemo alone. While media overall survival has not yet been reached, and this result doesn’t achieve statistical significance, some observers believe it suggests a favorable trend.
Also noteworthy are two big data releases from combination trials in breast cancer. The first is Eli Lilly’s MONARCH-2 study of abemaciclib (CDK 4/6 inhibitor) plus AstraZeneca’s Faslodex (fulvestrant) in hormone receptor positive, Her-2 negative advanced breast cancer. The study posted a median progression-free survival rate of 16.4 months with a hazard ration of 0.55, which out-performed the 9.3 month survival benefit for Faslodex alone. While some analysts note that this data compares favorably with that exhibited by Pfizer’s Ibrance (palbociclid), Lilly’s drug was also associated with a high rate (90%) of diarrhea that could prove a problem for patients who would need to take the drug for many months in the case of metastatic disease or a couple of years in the adjuvant setting. Abemaciclib will also face competition from Novartis’ ribociclib, which will also have data in advanced breast cancer at ASCO.
The second breast cancer study to watch for is the full results of Roche/Genentech’s Phase 3 APHINITY trial in Her-2 positive early breast cancer, combining Perjeta (pertuzumab) with Herceptin (trastuzumab) and chemotherapy. While Roche has said that the combination of Perjeta, Herceptin and chemo outperformed Herceptin and chemo alone, they are saving any news on the magnitude of the improvement for ASCO.
Speaking of combination therapies, a lot of attention is being given to IDO inhibitors as a rapidly emerging area of focus. Incyte has released promising data that led to a nearly 10% jump in their stock price, reporting that combining Epacadostat with Keytruda led to a 35% overall response rate in NSCLC patients, in contrast to about 18% for Keytruda alone. Moreover, the data suggest this gain was achieved with not much added toxicity, spurring still more interest in combination approaches with IDO inhibitors. Incyte has Phase 3 trials ongoing in other solid tumor types (bladder, head and neck, and renal) and results are early and not uniformly encouraging.
NewLink Genetics will also be presenting data from two studies of their IDO inhibitors, indoximod & navoximod which work by different mechanisms to intervene in the IDO pathway. Results of a Phase 2 study combining indoximod with PROVENGE in metastatic, castration-resistant prostate cancer saw a statistically significant improvement in progression-free survival, to 10.3 months for the combination versus 4.1 months for PROVENGE plus placebo. Median overall survival has not yet been reached in this study and there has been no increase in adverse events for the combination versus PROVENGE alone. Data from a Phase 1b study combining Navoximod with Roche’s Tecentriq has been somewhat less promising however, with only partial responses in 9% of patients with a variety of solid tumor types in this early study. This leads to the question of whether the IDO inhibitors will show different activity profiles in the clinic, and whether they may have differing efficacy amongst indications and combination regimens.
Finally, along with the focus on combinations, comes continued discussion and data regarding biomarkers, especially for immuno-oncology — both as a means of predicting efficacy and safety, and also for identifying the most appropriate patients for various IO combinations. Other diagnostic-related topics to watch include new data on liquid biopsy, including its impact on outcomes and potential future uses of the technology; a session on big data and how it can be used to improve outcomes; and biomarkers that enable tumor agnostic approaches, including discussion of regulatory considerations, target selection and related topics.
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