Every year ASCO is a highlight in our calendar, where vast amounts of clinical data are unveiled, presented, and discussed. This year is no exception, and there will be plenty of high-impact presentations to watch out for. Here, in part one of our two “Hot Topics at ASCO” blogs, we focus on abstracts that we think will prove to be key highlights in the first few days of the conference. Check out our helpful guides below on how to make sure you catch the best presentations.
Opdivo plus Yervoy in first-line advanced NSCLC: Results from CheckMate-012. Abstract 9093
After the failure of Opdivo to meet its endpoint in the CheckMate-026 trial, combination trials evaluating the Opdivo plus Yervoy combination are crucial for Bristol-Myers Squibb to capture any market share in first-line NSCLC. Following the company's announcement back in January that they will not seek accelerated approval for Opdivo plus Yervoy in the first-line setting, release of OS data from CheckMate-012 are eagerly anticipated. Encouraging results could help BMS stave off competition in the short run, while negative results could further frustrate the company's hopes of big sales in first-line NSCLC.
Pegylated human IL-10 (AM0010) plus FOLFOX in metastatic pancreatic adenocarcinoma. Abstract 4111
In pancreatic cancer, AM0010, a pegylated IL-10 therapy, is being investigated in a Phase III trial in combination with FOLFOX in second-line patients. In the interim analysis presented at ASCO 2017, ARMO Biosciences will present a 16% ORR and 74% DCR by AM0010 therapy. Given the limited success seen to date with immune checkpoint inhibitors in pancreatic cancer, this agent could pioneer the application of immunotherapy in this poor-prognosis and high unmet need disease.
Results from the Phase III OlympiAD trial of Lynparza in breast cancer. Abstract LBA4
Several PARP inhibitors are in late-Phase development for BRCA-mutated breast cancer, and the OlympiAD results of Lynparza will be the first of these trials to be reported. The PARP inhibitors have had a turbulent history in breast cancer, with the high profile rise and fall of iniparib several years ago which caused other companies to re-evaluate their development strategy for this class of agents. The BRCA-mutated population is selected owing to its high likelihood to respond to PARP inhibitors, so hopes are high for the OlympiAD data, not least because a large number of BRCA-mutated breast cancer patients fall into the triple-negative breast cancer population, which is an area of high unmet need.
Updated results of Kisqali plus letrozole from the MONALEESA-2 trial in first-line HR-positive, HER2-negative breast cancer. Abstract 1038
Preliminary data presented last year showed that patients treated with CDK4/6 inhibitor Kisqali plus letrozole (compared with those on letrozole alone) had not reached the PFS cut-off (vs. 14.7 months in the letrozole arm). The data also indicated that PFS was increased in patients with de novo advanced/metastatic HR+/HER2- disease treated with Kisqali + letrozole. The MONALEESA-2 trial design is similar to that of PALOMA-1 and -2, which support first-to-market CDK4/6 inhibitor Ibrance's use in the first-line. Data presented here will show the exact benefit produced by Kisqali and allow an indirect comparison with its competitor, Ibrance.
Adjuvant Yervoy at 3 or 10mg/kg vs. high-dose interferon alfa-2b for resected high-risk melanoma. Abstract 9500
In October 2015 the FDA granted a label expansion to Yervoy at a dose of 10mg/kg for adjuvant resectable melanoma, however, its prior approval in the metastatic setting was at a dose of 3mg/kg, so the results of this trial will settle the debate over which dose should be used in adjuvant patients. Moreover, results from this trial (if positive) are likely to support regulatory filings outside of the United States. While these preliminary data are unlikely to resolve all the questions surrounding Yervoy’s dosing immediately, they will be able to answer whether short term efficacy looks comparable, and how much the toxicity profile of the two regimens differs. Discontinuation due to adverse events was 52% in trial that lead to approval of Yervoy at 10mg/kg, if the 3mg/kg dose is able to still confer efficacy benefits while reducing toxicities, it will be a much more appealing regimen.
Lenvima versus Nexavar as a first-line treatment for unresectable hepatocellular carcinoma. Abstract 4001
As the longest approved targeted agent for HCC, Nexavar is well-entrenched as the advanced first-line standard of care. Earlier this year, Eisai announced that its Phase III trial of first-line Lenvima had met the primary endpoint of a statistically non-inferior OS when compared to Nexavar. With the trial also showing that Lenvima offers significant improvements in secondary endpoints—such as PFS, TTP, and ORR—Eisai is now expected to discuss these findings with global regulatory authorities before filing for approval. Approvals based on non-inferior OS data are however scarce and therefore, it will indeed be interesting to see how the regulatory authorities perceive these data. An approval for Lenvima in this setting could provide a much needed option for the treatment of HCC, although its impact could eventually be limited should Opdivo also receive first-line approval.
Results of Zytiga in newly diagnosed high-risk metastatic hormone-naïve prostate cancer (LATITUDE). Abstract LBA3
Results from the LATITUDE trial have been eagerly anticipated by physicians, as it could see the use of Zytiga shift up the prostate cancer treatment algorithm into the newly diagnosed hormone-sensitive population. According to Janssen’s company pipeline, Zytiga was filed for regulatory approval in newly diagnosed hormone naive metastatic prostate cancer in April 2017. If the data from LATITUDE support regulatory approval it could bolster sales of Zytiga, which in 2016 were over $2 billion globally from use in metastatic castrate resistant prostate cancer. Such an approval would be a big win for Janssen as it would be the only second generation hormonal agent to enter the hormone-sensitive prostate cancer setting.
Decision Resources Group will be at ASCO 2017 at booth #22115 in the Exhibitors Hall, we look forward to seeing you there!