Oppenheimer analyst Leland Gershell raised his price target for Amarin (AMRN) to $13 from $8 as AstraZeneca (AZN) appears to have no plans to ever launch Epanova. The analyst notes that AstraZeneca has announced plans to close its large CV outcomes trial of Epanova based on a recommendation from the trial's independent data monitoring committee which determined that STRENGTH would be unlikely to demonstrate benefit in the mixed dyslipidemia patient population at increased risk of CV disease. Gershell has an Outperform rating on Amarin's shares.
Detailed primary results from the Phase II DESTINY-Lung01 trial of ENHERTU, the AstraZeneca and Daiichi Sankyo HER2-directed antibody drug conjugate, showed a robust and durable tumor response in previously treated patients with HER2-mutant unresectable and/or metastatic non-squamous non-small cell lung cancer. Results presented during a late-breaking Proffered Paper session at the European Society for Medical Oncology Congress 2021 and simultaneously published in The New England Journal of Medicine confirm ENHERTU as the first HER2-directed therapy to show a strong tumor response in this patient population. Primary results from the HER2m cohort of DESTINY-Lung01 in previously treated HER2m NSCLC demonstrated a confirmed objective response rate of 54.9% in patients treated with ENHERTU as assessed by independent central review. One complete response and 49 partial responses were observed. A confirmed disease control rate of 92.3% was seen with a reduction in tumor size observed in most patients. After a median follow-up of 13.1 months, the median duration of response for ENHERTU was 9.3 months. The median progression-free survival was 8.2 months and the median overall survival was 17.8 months. Responses were observed across HER2m subtypes, as well as in patients with no detectable HER2 expression or HER2 gene amplification. Efficacy was observed in subgroups including prior treatment with platinum-based therapy, or platinum-based and anti-PD-(L)1 therapy, as well as asymptomatic brain metastases at baseline.
Detailed positive results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu, or trastuzumab deruxtecan,, the AstraZeneca and Daiichi Sankyo HER2-directed antibody drug conjugate, demonstrated superior progression-free survival versus trastuzumab emtansine, a HER2-directed ADC currently approved to treat patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. Results were presented in a Presidential Symposium at the European Society for Medical Oncology Congress 2021. At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1. After 15.5 and 13.9 months of follow-up in the Enhertu and T-DM1 arms respectively, the median PFS for patients treated with Enhertu was not reached compared to 6.8 months for T-DM1 as assessed by blinded independent central review. In the key secondary endpoint of PFS assessed by investigators, patients treated with Enhertu experienced a three-fold improvement in PFS of 25.1 months versus 7.2 months for T-DM1. A consistent PFS benefit was observed in key subgroups of patients treated with Enhertu, including those with a history of stable brain metastases. There was a strong trend towards improved overall survival with Enhertu, however this analysis is not yet mature and is not statistically significant. Nearly all patients treated with Enhertu were alive at one year compared to 85.9% of patients treated with T-DM1. Confirmed objective response rate more than doubled in the Enhertu arm versus the T-DM1 arm. Forty-two complete responses, and 166 partial responses were observed in patients treated with Enhertu compared to 23 CRs and 67 PRs in patients treated with T-DM1. The safety profile of the most common adverse events with Enhertu in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. There were 27 cases of treatment-related interstitial lung disease or pneumonitis reported, as determined by an independent adjudication committee. The majority were low Grade, with two Grade 3 events reported. No Grade 4 or Grade 5 ILD or pneumonitis events occurred.