AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval

Editor's note: this story was originally published on BioPharmInternational.com.

AstraZeneca’s Imfinzi (durvalumab), a human monoclonal antibody (mAb), was approved by FDA earlier this month in combination with chemotherapy for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. Following this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery, according to an Aug. 16, 2024 company press release.

Also in August 2024, Imfiniza and Lynparza (olaparib) were approved throughout the European Union (EU) for treating certain patients with primary advanced or recurrent endometrial cancer (1). With this EU approval, Imfinzi plus chemotherapy can be used as first-line treatment, followed by treatment with Imfiniza and Lynparza (olaparib). In addition, Imfinzi, may be used to treat patients with mismatch repair proficient disease. A regimen using Imfinzi plus chemotherapy, followed by Imfinzi alone, can also be used for treating patients with mismatch repair deficient (dMMR) (1).

FDA’s latest approval was based on positive results from a pivotal Phase III trial (AEGEAN), which showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death before and after surgery in patients treated with Imfinzi in combination with chemotherapy versus chemotherapy alone. These results were published in The New England Journal of Medicine in October 2023 (2).

“This approval brings an important new treatment option that should become a backbone combination approach for patients with resectable non-small cell lung cancer, who have historically faced high rates of recurrence even after chemotherapy and surgery. When added both before and after surgery, durvalumab delivered a significant and meaningful improvement in outcomes in this curative-intent setting,” said John V. Heymach, MD, PhD, professor and chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, in the AstraZeneca press release.

Imfinzi was shown to be well tolerated, AstraZeneca stated in the press release. Furthermore, no new safety signals were observed in the neoadjuvant and adjuvant settings. Adding Imfinzi to neoadjuvant chemotherapy showed consistency with the known profile for this combination and did not compromise patients' ability to complete surgery, compared to chemotherapy alone.

“Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches [such as] AEGEAN to early lung cancer settings where cure is the goal of treatment,” said Dave Fredrickson, executive vice-president, Oncology Business Unit, AstraZeneca, in the press release.

In addition to the United States, Imfinzi is approved in the United Kingdom, Switzerland, and Taiwan (China) for this indication, also based on the Phase III (AEGEAN) results. Furthermore, the company has regulatory applications under review in the EU, China, and several other countries in this indication.

Further to its application in the treatment of lung cancers, Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) for treating locally advanced or metastatic biliary tract cancer and in combination with AstraZeneca’s Imjudo (tremelimumab), a mAb that blocks the activity of cytotoxic T-lymphocyte-associated protein 4 to aid in activating T-cells, for treating unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved in Japan and the EU as a monotherapy for unresectable HCC as well as in the US in combination with chemotherapy (carboplatin plus paclitaxel), followed by Imfinzi monotherapy, for treating primary advanced or recurrent endometrial cancer that is dMMR.

References

1. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
2. Heymach, J. V.; Harpole, D.; Mitsudomi, T.; et al. Perioperative Durvalumab for Resectable Non–Small-Cell Lung Cancer. N. Engl. J. Med. 2023, 389 (18),1672–1684. DOI: 10.1056/NEJMoa2304875

Source: AstraZeneca