Potentials So to sum it up the drug had over 100 per cent YOY sale growth yet it can cost about US 10 k every three weeks. With half the patients taking it for 7 or more months it can generate revenuers at about 100k per patient per year.
The drug is currently labelled for breast cancers with at least two previous HER2 treatments for metastatic breast cancer, effective(progression free survival 8.5 months, overall survival 18.2 months but some safety issues(mostly blood related ,neutropenia, anemia, leukopenia..) so it wipes out both white and red blood cells causing opportunistic infections and fatigue etc. which seems to be within the safety zone of authorities for approvals for metastatic cancers! now they can expand the label as the protein is over expressed in only 20 per cent of breast cancers therefore much bigger targeted market!
My take from all the below low bar in terms of severity of adverse effects for late stage cancer drugs so a well-tolerated drug will be a significant advantage not only in the approval process but also financially adding 5 or more months PFS, 10 or months OS will be more than sufficient to satisfy the authorities and quite lucrative growing revenues if and when a drug is approved. If and when the drug is approved the follow up studies can possibly expand the label significantly. These are the potentials of TH1902 which can multiply based on each cancer they are targeting.
“Enhertu was approved in late 2019 and has global revenues of $426 million in 2021 ($202 million in 2020)”
https://www.drugs.com/price-guide/enhertu
“In this trial involving patients with HER2-low metastatic breast cancer, trastuzumab deruxtecan resulted in significantly longer progression-free and overall survival than the physician’s choice of chemotherapy.”
Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer | NEJM
More from AZ!
“Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: Today’s results represent a pivotal moment demonstrating the potential for Enhertu to redefine the treatment of HER2-targetable cancers. DESTINY-Breast04 validates targeting the lower end of the spectrum of HER2 expression, since Enhertu reduced the risk of disease progression or death across all types of patients in the trial by half, and reduced the risk of death by over a third.”
The efficacy!
“In an exploratory analysis of patients with HR-negative disease , median PFS was 8.5 months with Enhertu versus 2.9 months with chemotherapy and median OS was 18.2 months with Enhertu versus 8.3 months with chemotherapy”
Side effects!
“The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. The most common Grade 3 or higher treatment-emergent adverse events were neutropenia (13.7%), anaemia (8.1%), fatigue (7.5%), leukopenia (6.5%), thrombocytopenia (5.1%), and nausea (4.6%).
Interstitial lung disease (ILD) or pneumonitis rates were consistent with that observed in late-line HER2-positive breast cancer trials of Enhertu with a lower rate of Grade 5 ILD observed, as determined by an independent adjudication committee. The majority (10%) were primarily low Grade (Grade 1 or 2) with five Grade 3 (1.3%), no Grade 4 and three Grade 5 (0.8%) events reported.”
https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-efficacy-results-in-her2-low-breast-cancer.html
Dosage and pricing:
“The cost for Enhertu intravenous powder for injection 100 mg is around $2,563 for a supply of 1 powder for injection, to treat HER2+ breast cancer, in most cases your dose will be your weight in kg multiplied by 5.4. For example, someone who weighs 150 lb (68 kg) would receive a dose of 367 mg of Enhertu.
Enhertu is typically given once every 3 weeks. You’ll continue taking it for as long as your doctor prescribes. You’ll likely continue treatment with Enhertu until your cancer gets worse or you develop side effects that affect your daily life.
The length of Enhertu treatment can vary. It’s possible that you may take the drug long term. In clinical studies, at least half of the people using Enhertu took it for 7 months or longer.”
https://www.medicalnewstoday.com/articles/enhertu#dosage