AstraZeneca Reports Strong 2020 Oncology Growth with Enhertu Generating $200M in First-Year Sales

On February 11, 2021, coinciding with the Chinese Spring Festival, AstraZeneca announced its 2020 financial results, reporting full-year revenue of $26.6 billion. Oncology, cardiovascular and renal metabolism, and respiratory therapies constitute AstraZeneca’s three core business areas. Among these, oncology has emerged as the most significant segment and is the company’s only rapidly growing business area. Oncology revenue reached $11.46 billion, representing a 24% year-over-year increase and contributing 43% of the company’s total performance. Osimertinib generated $4.3 billion in revenue, marking a substantial 36% growth. The cardiovascular and renal metabolism business recorded revenue of $5.4 billion, with dapagliflozin contributing $1.959 billion, reflecting a 27% year-over-year increase.

Overall, the most noteworthy aspects of AstraZeneca's 2020 financial report are:

1. Oncology has become the company’s most pivotal therapeutic area. The first agent to highlight is osimertinib, the representative third-generation EGFR tyrosine kinase inhibitor. Following its initial approval for first-line treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC), osimertinib further gained approval for adjuvant therapy in patients with stage II–IIIA EGFR-mutated NSCLC after surgical resection, supported by the superior clinical benefits demonstrated in the ADAURA trial. With this significant expansion of indications, osimertinib has undergone a remarkable transformation, and its future growth prospects remain highly promising.

2. Durvalumab is another blockbuster product in the oncology portfolio, indicated for consolidation therapy in patients with stage III non-small cell lung cancer (NSCLC) who have achieved disease stability following platinum-based chemoradiotherapy, while also expanding into first-line treatment for extensive-stage small cell lung cancer. Although durvalumab has achieved rapid growth for four consecutive years, it has made progress in first-line treatments for non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma, yet has not achieved breakthroughs in early-stage neoadjuvant/adjuvant cancer therapy; its performance in 2021 is expected to show low double-digit growth;

3. Olaparib and Acalabrutinib are also rapidly growing products within the oncology portfolio. Key areas of future interest for these two agents include: progress with the olaparib and pembrolizumab combination regimen, particularly in first-line maintenance therapy for advanced non-small cell lung cancer (NSCLC); acalabrutinib has been approved for first-line treatment of chronic lymphocytic leukemia (CLL), and has demonstrated non-inferiority compared to ibrutinib in CLL.

4. Cardiovascular System: Dapagliflozin is another noteworthy agent. Beyond diabetes, robust data from the DAPA-HF and DAPA-CKD trials support its expansion into the fields of heart failure and chronic kidney disease, and it is expected to continue its rapid growth in the future.

5. Novel Coronavirus: AstraZeneca has developed prevention and treatment regimens for COVID-19, including the ChAdOx1 nCoV-19 vaccine for prevention; and therapeutic options such as the tixagevimab/cilgavimab cocktail therapy and acalabrutinib.

I. Third-Generation EGFR Inhibitors: Tagrisso Has Emerged as the Top Performer in EGFR-Mutated Non-Small Cell Lung Cancer

https://www.astrazeneca.com/content/dam/az/PDF/2020/full-year/Full-year_2020_results_presentation.pdf

Breakthroughs in early-stage lung cancer (Stage I/II/III) will determine the long-term growth of osimertinib. Market sales in 2021 are expected to maintain high double-digit growth. The approval of osimertinib for postoperative adjuvant therapy in early-stage lung cancer in 2020 represents a significant breakthrough in the treatment of non-small cell lung cancer (NSCLC).

At the 2020 ASCO Annual Meeting, data from the ADAURA trial (NCT02511106) demonstrated that osimertinib significantly prolonged disease-free survival (DFS) compared with placebo in patients with stage II/IIIA non-small cell lung cancer (NSCLC), with 2-year DFS rates of 90% versus 34% (HR 0.17).

To date, osimertinib has become the new standard of care for EGFR-mutated non-small cell lung cancer!

ADAURA Trial Protocol:

II. Expansion into Key Indications Remains Challenging; 2021 Growth Expected to Slow

Imfinzi is the second PD-L1 monoclonal antibody approved for marketing globally. Compared with Roche, AstraZeneca’s expansion of key indications for Imfinzi has not been smooth; currently, its major indications are limited to consolidation therapy in stage III non-small cell lung cancer (NSCLC) and first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

AstraZeneca’s latest annual report highlights several clinical trials of durvalumab that warrant close attention: 1. In lung cancer indications, the Phase III POSEIDON trial for first-line treatment of Stage IV non-small cell lung cancer (NSCLC) was successful; whether this will support the approval of durvalumab remains to be seen and requires continued monitoring. 2. For advanced cancers, ongoing projects include POTOMAC, NIAGARA, and NILE in bladder cancer; KUNLUN in esophageal cancer; MATTERHORN in gastric/gastroesophageal junction cancer; and EMERALD-1/2 in hepatocellular carcinoma. 3. For neoadjuvant or adjuvant therapy in early-stage cancer, the AEGEAN and ADJUVANT trials are evaluating neoadjuvant treatments for NSCLC. For further details, please refer to the appendix at the end of this article.

III. Acalabrutinib: Non-inferior to Ibrutinib in Chronic Lymphocytic Leukemia

https://www.astrazeneca.com/content/dam/az/PDF/2020/full-year/Full-year_2020_results_presentation.pdf

Four BTK inhibitors have been approved for marketing in various countries and regions worldwide. Among them, the first-in-class agent ibrutinib was approved on November 13, 2013, and rapidly gained market traction, with global sales reaching USD 6.616 billion in 2020, a year-on-year increase of 16.3%. AstraZeneca’s acalabrutinib was approved in the United States four years later, with its 2020 sales rising to USD 520 million, still significantly lagging behind ibrutinib. Although clinical data from trial NCT02477696 demonstrated that acalabrutinib provided benefits in chronic lymphocytic leukemia compared with ibrutinib, showing non-inferiority and a superior safety profile, it did not demonstrate superiority in clinical benefit and continues to face intense competition from ibrutinib.

IV. Enhertu Will Become the New Standard of Care for Breast Cancer, with First-Year Sales Reaching $200 Million

https://www.daiichisankyo.com/files/investors/library/materials/2020/pdf/20210113%E2%80%97JPM%20Conference.pdf

AstraZeneca’s oncology business will continue to grow. In 2021, the most noteworthy developments remain those related to durvalumab, olaparib, and trastuzumab deruxtecan; the various advancements outlined in the table below warrant particular attention.

https://www.astrazeneca.com/content/dam/az/PDF/2020/full-year/Full-year_2020_results_announcement.pdf

Appendix: AstraZeneca Pharmaceutical Business 2020 Performance (in million USD)

The Most Notable Clinical Program of Durvalumab