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AstraZeneca Hopes to Replace Chemotherapy With Targeted Treatments Across Breast Cancer Subtypes


NEW YORK – AstraZeneca is aiming to entirely replace chemotherapy in the late-line breast cancer setting across all subtypes with its targeted therapies including Enhertu (trastuzumab deruxtecan) and Trop2-targeted antibody-drug conjugate Dato-DXd (datopotamab deruxtecan).

AstraZeneca executives outlined this strategy during a call Friday to discuss the company's financial performance in Q2 of 2023, in which the firm's total revenue rose 9 percent to $11.42 billion compared to Q2 2022. On average, analysts were expecting $10.96 billion. Oncology products contributed $4.38 billion in Q2 2023, increasing 18 percent or 22 percent at CER over the year-ago period.

Discussing the company's breast cancer portfolio on the call, Dave Frederickson, executive VP of AstraZeneca's oncology business, said, "What we're really seeking on this is category leadership within breast cancer."

He estimated that within the G7 countries — the US, Canada, France, Germany, Italy, Japan, and the United Kingdom — there are about 35,000 breast cancer patients in the fourth-line and beyond settings across HER2-positive and HER2-negative disease. Frederickson said that with Enhertu and Dato-DXd, the company is positioned to, in the future, market an AstraZeneca medicine appropriate for each of the different subtypes and stages of treatment in breast cancer, with an "opportunity to replace chemotherapy across late-line breast cancer as a category."

Sales of Enhertu, which AstraZeneca markets with Daiichi Sankyo, were $67 million in the second quarter of 2023, up more than threefold at CER over its sales in the year-ago period. Enhertu, a HER2-targeted antibody drug conjugate, was approved by the US Food and Drug Administration in May 2022 as a second-line therapy for HER2-positive breast cancer based on results from the DESTINY-Breast03 Phase III trial, in which treatment with Enhertu reduced the risk of disease progression or death by 72 percent compared to Genentech's HER2-targeted antibody-drug conjugate Kadcyla (trastuzumab emtansine). Enhertu was subsequently approved in August 2022 for patients with HER2-low breast cancer following prior chemotherapy.

While Enhertu is on track to address patients with HER2-positive and HER2-low disease, AstraZeneca is lining up its Dato-DXd for patients with HER2-negative breast cancer. The company is anticipating the first readout later this year from the Phase III TROPION-Breast01 trial of Dato-DXd versus investigator's choice of chemotherapy in patients with inoperable or metastatic HR-positive, HER2-negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy. AstraZeneca is developing Dato-DXd in multiple cancers, including lung and breast.

Susan Galbraith, executive VP of Oncology R&D for AstraZeneca, said that early results from the HR-positive cohort of TROPION-PanTumor01 showed a disease control rate of 85 percent and a median progression-free survival of 8.3 months in a heavily pre-treated population, giving the company confidence in the success of TROPION-Breast01. AstraZeneca is also investigating whether Dato-DXd can replace chemotherapy in first-line patients not eligible for PD-1 or PD-L1 inhibition in TROPION-Breast02 and the role of adjuvant Dato-DXd in triple-negative breast cancer with or without Imfinzi (durvalumab) in TROPION-Breast03.

AstraZeneca's other precision oncology drugs turned in strong sales in Q2. Its tyrosine kinase inhibitor Tagrisso (osimertinib) recorded sales of $1.49 billion in Q2 2023, an increase of 7 percent (10 percent at CER) compared to Q2 2022. The firm markets Tagrisso as an adjuvant and first-line therapy for EGFR-mutated non-small cell lung cancer.

Frederickson said the growth in sales reflected "strong underlying demand" for Tagrisso based on results from the Phase III ADAURA and FLAURA clinical trials. FLAURA showed that treatment with Tagrisso was superior to AstraZeneca and Teva's Iressa (gefitinib) or Astellas and Roche's Tarceva (erlotinib) as a first-line therapy in EGFR-positive advanced NSCLC. In results presented at the American Society of Clinical Oncologists annual meeting in June, ADAURA demonstrated an overall survival advantage five years after treatment for patients with stage IB to IIIA EGFR-mutated NSCLC. Following that presentation, Frederickson said, "We expect expanded use of Tagrisso in the adjuvant setting as well as potential for new reimbursements in certain geographies."

Q2 2023 sales of the PARP inhibitor Lynparza (olaparib) increased 7 percent (9 percent at CER) to $717 million and sales of PD-L1 inhibitor Imfinzi increased by 55 percent (58 percent at CER) to $1.08 billion compared to the year-ago quarter.

AstraZeneca also announced an agreement this morning with Alexion to acquire a portfolio of gene therapy programs from Pfizer. The deal will add a number of novel adeno-associated virus capsids to Alexion and AstraZeneca's genomic medicine capabilities. "We aim to address a number of genetic diseases across liver, kidney, heart, muscle, and [central nervous system]," Alexion CEO Marc Dunoyer said in the call. "We look forward to welcoming Pfizer employees, increasing our gene therapy team to over 80 specialists."

AstraZeneca posted net income of $1.82 billion, or $1.17 per share, for the quarter compared to a net profit of $360 million, or $.23 per share, in Q2 2022. The consensus Wall Street EPS estimate was $0.95.

Part of the large jump in net profit was due to items included under "other operating income" on the firm's earnings statement. These items include a $712 million gain that resulted from an update to its contractual relationships for Beyfortus (nirsevimab), which received US Food and Drug Administration clearance less than two weeks ago for preventing respiratory syncytial virus in infants and children; a $241 million gain on the disposal of US rights to asthma therapy Pulmicort Flexhaler; and other proceeds based on the sale of tangible assets, as well as royalties on certain therapies.

The firm finished the quarter with $5.81 billion in cash and investments.