ASCO Update: A Theme of Accessibility and Pricing Plus Individual Reporting
With the 2021 American Society of Clinical Oncology Annual Meeting now in high gear, there is plenty of news. Here’s a look at just some of the most recent stories.
A Focus on Accessibility and Pricing
Although ASCO is filled with clinical trial updates (see below), there appears to be a theme. That theme is access to drugs, and it was emphasized by the organization’s selection of a late-breaking study about Junshi’s toripalimab, which is the 10th anti-PD-L1 checkpoint inhibitor likely to be launched in the U.S.
The drug is marketed as Tuoyi in China under a deal with AstraZeneca, and is being filed in the U.S. with a deal with Coherus. The fact that toripalimab is such a late-comer to the immuno-oncology field would barely raise an eyebrow normally, but Coherus declares its mission is “to increase access to cost-effective medicines.” And they are expected to undercut everybody else on price. Price competition is not common yet in the immuno-oncology field.
The study being presented is JUPITER-02 of toripalimab for front-line nasopharyngeal carcinoma, which is more common in Asia than the U.S. In Asia, it makes up 70% of new diagnoses in the world. But no other anti-PD-L1 checkpoint inhibitors are authorized for it in the U.S. Rui Hua Xu of Sun Yat-Sen University Cancer Center presented data for the study demonstrating a 48% reduction in risk of progression for toripalimab plus chemotherapy compared to chemotherapy alone.
Bristol Myers Squibb’s Opdivo and Yervoy in Esophageal Cancer
Bristol Myers Squibb presented data from the Phase III CheckMate -648 trial. There were two combinations, Opdivo (nivolumab) plus chemotherapy and Opdivo plus Yervoy (ipilimumab). Both demonstrated statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at the interim analysis in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression greater than or equal to 1%, as well as in the all-randomized population. The Opdivo-Yervoy combination is the first time dual immunotherapy has demonstrated a superior survival benefit compared to chemotherapy in this setting.
Arcus Bioscience’s Etrumadenant and Zimberelimab in Prostate Cancer
Arcus Biosciences presented initial efficacy and safety data from one of the cohorts in its Phase Ib/II ARC-6 study of etrumadenant and zimberelimab and docetaxel in people with taxane-naïve metastatic castrate-resistant prostate cancer who progressed after treatment with one or more new hormonal agents and were checkpoint inhibitor-naïve. Etrumadenant is a dual adenosine A2A/A2b receptor antagonist. Zimberelimab is an anti-PD1 checkpoint inhibitor.
Agendia Presented Differences in Tumor Biology Between Ethnic Groups
Agendia gave an oral presentation on new data from the national FLEX registry that identified differences in tumor biology between ethnic groups. Not only does this support the need for diversity in breast cancer trials, but it might lead to better treatment decisions.
The FLEX study plans to enroll 30,000 patients from various ethnicities, ages, and demographic groups out of the total breast cancer population over 10 years. So far they have enrolled 7,500. It was presented by Kent Hoskins, co-leader of the Breast Cancer Research Group and director of Cancer Genetics at the University of Illinois Cancer Center. The presentation highlighted significant differences in luminal breast tumors between African American and non-Hispanic White women.
Hoskins said, “The data presented at ASCO 2021 show significant transcriptomic differences between Luminal tumors from African American and non-Hispanic White patients, seen even more starkly as our study controlled for age, obesity, and genomic classification. The data show ER+ breast cancers in African American women more often had upregulation of the mTOR pathway and cell cycle genes, which require different treatment approaches than other ER+ breast cancers.”
Novartis’ Full Plate of Study Results
Novartis is presenting a broad range of studies at ASCO. They announced the results of the Phase III VISION trial of 117Lu-PSMA-617, a targeted radioligand therapy and standard of care, which demonstrated significant improvement in OS compared to SOC alone in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.
The company also presented an overall survival analysis from MONALEESA-3 of Kisqali (ribociclib) for HR+/HER2- advanced breast cancer; long-term disease control in patients with PIK3CA-altered advanced breast cancer treated with alpelisib and fulvestrant and others. Novartis also presented data from the primary analysis of the Phase II ELARA trial of Kymriah (tisagenlecleucel) in r/r follicular lymphoma (FL). There was a 66% CR, 86% ORR, with median DOR in all responders, PFS and OS were not reached.
Nanobotix’s Radioenhancer NBTXR3 in Combination with Checkpoint Inhibitors
Nanobiotix presented results from its first-in-class radioenhancer NBTXR3 in combination with an anti-PD-1 checkpoint inhibitor, which converted patients who did not respond to checkpoint inhibitors into responders. The objective response was 60% in anti-PD-1 naive patients and 50% of previous non-responders. So far, the overall adverse event profile for the 16 patients is no different from what was expected with radiotherapy or checkpoint inhibitors. The primary tumors investigated were for head and neck cancer and non-small cell lung cancer.
“Improving response rates to immune checkpoint inhibitors is currently a key challenge for the medical and scientific community,” said Ganguy Seiwert, director of the head and neck oncology disease group at Johns Hopkins Medicine. “The data we have seen to date suggest that NBTXR3 could bring a completely different local and systemic approach to overcoming this barrier in immunotherapy.”