A Look at This Year's ASCO Pipeline

Immunotherapy agents targeting the PD-1/PD-L1 pathway will be the most robust area for news at the 2016 ASCO Annual Meeting, but there will be much new data about recently approved and novel anticancer drugs for clinicians to digest.

That is the picture of the oncology pipeline that emerges from the research that pharmaceutical companies plan to showcase at the annual gathering, which will be held June 3-7 in Chicago.

As has been the case in recent years, antibodies that target immune checkpoints continue to command attention in a growing number of tumor types. Notably, however, this year’s meeting also will feature updates on pivotal confirmatory trials for several agents that have gained accelerated approvals from the FDA based on earlier clinical trial results.

Here are the highlights of what companies plan to offer at ASCO this year:

• AbbVie—New data for venetoclax (Venclexta), a BCL-2 inhibitor that the FDA approved in April for the treatment of patients with 17p del chronic lymphocytic leukemia (CLL), will be presented in several hematologic malignancies, notably in acute myeloid leukemia. Abstracts 7007, 7009. AbbVie also plans presentations on ibrutinib (Imbruvica) and elotuzumab (Empliciti) along with several emerging agents. https://goo.gl/xlx9oo

• Amgen—A new subgroup analysis from the phase III ASPIRE trial that evaluated the addition of carfilzomib (Kyprolis) to lenalidomide and dexamethasone in patients with relapsed multiple myeloma tops Amgen’s list of research updates to be presented during the conference. The drug was approved in that setting in July 2015. Abstract 8045. http://goo.gl/zIjxWw

• Ariad—Brigatinib (AP26113), a receptor tyrosine kinase inhibitor, is being developed for patients with ALK-positive non—small cell lung cancer (NSCLC) under a breakthrough therapy designation. First results from the phase II ALTA trial among patients with crizotinib-refractory NSCLC will be presented at ASCO. The company expects to file a new drug application during the third quarter of 2016. Abstract 9007. http://goo.gl/vzZ4wo

• AstraZeneca—Emerging agents that target different elements of DNA damage response (DDR) mechanisms will be showcased at ASCO, most notably with research into the PARP inhibitor olaparib (Lynparza) as maintenance therapy in ovarian cancer. Abstract 5501. Additionally, the company will highlight research into osimertinib (Tagrisso) in patients with NSCLC who develop brain metastases and preliminary results of acalabrutinib as first-line therapy in CLL. Abstracts 9002, 7521. https://goo.gl/ljNfJm

• Bayer—Studies into radium-223 (Xofigo) in metastatic castration-resistant prostate cancer and regorafenib (Stivarga) form the backbone of research that Bayer is presenting at ASCO, including approved and emerging agents. http://goo.gl/ylDzFX

• Bristol-Myers Squibb—Updated phase III overall survival (OS) findings for nivolumab (Opdivo) in metastatic squamous cell carcinoma of the head and neck are among the potential practice-changing results expected from this year’s ASCO meeting. The PD-1 inhibitor is being evaluated for this patient population under a breakthrough therapy designation. Abstract 6009. Bristol-Myers also will present nivolumab research in NSCLC, small cell lung cancer, melanoma, renal cell carcinoma (RCC), metastatic urothelial carcinoma (mUC), and colorectal cancer. Additionally, the company will report findings for a range of other agents and tumor types. http://goo.gl/82ssJQ

• Celgene—A meta-analysis of OS data for lenalidomide (Revlimid) maintenance therapy following high-dose melphalan and autologous stem cell transplant in patients with multiple myeloma is among a variety of research into existing and emerging therapies that Celgene will present at ASCO. Abstract 8001. http://goo.gl/Yk46Fd

• Eisai—Subgroup analyses and updated OS findings will be presented for the combination of lenvatinib (Lenvima) and everolimus in advanced RCC from Study 205, which formed the basis of the drug’s approval in this setting in May 2016 following a breakthrough therapy designation. Abstract 4553. http://goo.gl/xwbtKV

• Eli Lilly—New data for abemaciclib, a CDK4/6 inhibitor, will be presented in hormone receptor—positive, HER2-negative breast cancer from the single-arm, phase II MONARCH1 trial. Research into several other novel agents also will be updated in multiple poster presentations. Abstract 510. http://goo.gl/t8ajDI

• Exelixis—New OS data from the phase III METEOR study into cabozantinib (Cabometyx/Cometriq) in patients with previously treated advanced RCC will headline the company’s ASCO presentations. Cabozantinib was approved in this patient population in April based on progression-free survival data. Abstract 4506. http://goo.gl/B9RIV

• Genentech—Findings from a phase II study evaluating the PD-L1 inhibitor atezolizumab (Tecentriq) as a first-line therapy for patients with mUC who are not candidates for cisplatin therapy are among the results that ASCO is highlighting at this year’s meeting. The agent was approved in mid-May for patients with advanced mUC, the most common form of bladder cancer, whose disease has progressed following platinum-containing therapy. Abstract LBA4500. The IMvigor210 study results are part of a suite of research into atezolizumab in several tumor types that will be reported at the meeting. Genentech plans to present more than 200 abstracts involving 19 therapies. http://goo.gl/ULNj46

• Incyte—Five-year outcomes data for ruxolitinib (Jakafi) therapy in patients with myelofibrosis from the phase III COMFORT-1 study highlight the company’s ASCO presentations, which also will feature additional research into the JAK inhibitor. Abstract 7012. Updates about the c-MET inhibitor capmatinib (INC280), which Incyte has licensed to Novartis for development, also are on the roster. http://goo.gl/2BVAuA

• Janssen—Pivotal trial results for daratumumab (Darzalex) in patients with multiple myeloma are among the featured research findings at this year’s meeting. In the phase III CASTOR study, daratumumab was added to the standard regimen of bortezomib (Velcade) plus dexathemasone among patients who had received at least 1 prior line of therapy. Abstract LBA4. https://goo.gl/rzLx4Q

• Merck—Long-term OS data for pembrolizumab (Keytruda) in patients with metastatic melanoma will be reported from 2 of the studies that have helped establish the PD-1 inhibitor. Two-year OS data and 3-year OS findings from the KEYNOTE-006 and KEYNOTE-001 trials, respectively, will be presented. Abstracts 9504, 9503. http://goo.gl/0z7Ews

• Novartis—The potential for treatment-free remission for patients with chronic myeloid leukemia in chronic phase who are treated with frontline nilotinib (Tasigna) will be detailed in results of the phase II ENESTFreedom study. Researchers say this is the first time this question has been explored in this setting. Abstract 7001. Other Novartis highlights include results from the SWISH study, in which a dexamethasone-based mouthwash was evaluated for the prevention of stomatitis among women with breast cancer who receive the mTOR inhibitor everolimus as part of their therapy. Abstract 525. https://goo.gl/6pSquT

• Pfizer—New findings for avelumab in metastatic Merkel cell carcinoma and in advanced unresectable mesothelioma will be in the spotlight as Pfizer, in collaboration with Merck KGaA, presents data for the PD-L1 inhibitor across multiple tumor types in the JAVELIN clinical trial program. Abstracts 9508, 8503. http://goo.gl/NDlhfI

Additionally, Pfizer will present updated primary data for palbociclib (Ibrance) in women with estrogen receptor—positive/HER2-negative advanced breast cancer from the phase III PALOMA-2, a confirmatory study for the CDK4/6 inhibitor. Abstract 507. http://goo.gl/40t2Dz

Full abstracts are available on ASCO’s site at www.am.asco.org.