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FDA Grants Breakthrough Therapy Designation To Trodelvy For Small Cell Lung Cancer

The FDA has granted breakthrough therapy designation Trodelvy for adults with extensive-stage small cell lung cancer who progressed on/after chemotherapy.

Trodelvy for Small Cell Lung Cancer

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy(sacituzumab govitecan-hziy) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy treatment.

According to a news release from theTrodelvy manufacturer Gilead Sciences, Inc., the designation was based on findings among the ES-SCLC cohort of the phase 2 TROPiCS-03 study which investigated Trodelvy as a second-line treatment option for ES-SCLC.

Breakthrough therapy designation, according to the FDA, is meant to speed up the development and review of drugs intended to treat a serious condition. ES-SCLC, according to the American Cancer Society, has spread widely throughout the lung to the other lung or to other parts of the body.

Study results presented at the 2024 IASLC World Conference on Lung Cancer and published in the Journal of Thoracic Oncology showed that, at a median follow-up of 12.3 months, the treatment resulted in an overall response rate of 41.9%, with all responses being confirmed as partial responses. According to the news release, Gilead intends to launch a phase 3 clinical trial of Trodelvy among patients with ES-SCLC.

Trodelvy is an antibody-drug conjugate which targets TROP2, a cell surface antigen expressed in more than 90% of breast and lung cancers, according to the news release.

Antibody-drug conjugates consist of an antibody linked to a cytotoxic payload, such as a chemotherapy drug, and are a form of targeted therapy — in the case of Trodelvy, targeting cells that express TROP2.

Glossary

Overall response rate: Patients who responded partially or completely to treatment.

Boxed warning: The most serious warning the FDA can issue for a drug.

Neutropenia: A low count of neutrophils, a type of white blood cell.

Leukocyte: White blood cells.

Hemoglobin: Oxygen-carrying protein in red blood cells.

Lymphocyte: A type of white blood cell.

Albumin: A protein in the blood, low levels of which can indicate liver or kidney damage.

Decreased creatinine clearance: A potential indication of kidney disease.

Increased alkaline phosphatase: A potential indication of liver disease.

Trodelvy is currently indicated in the United States for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies and unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting, according to the announcement from Gilead.

Trodelvy comes with boxed warnings for neutropenia and diarrhea, with the company noting that severe or life-threatening neutropenia and severe diarrhea may occur. Neutropenia occurred in 64% of patients treated with Trodelvy, with grade 3 (severe) to 4 (life-threatening) occurring in in 49% of patients. Diarrhea occurred in 64% of patients who received Trodelvy, with grade 3 to 4 diarrhea occurring in 11% of patients.

Regarding side effects, the manufacturer stated that in the pooled safety population the most common side effects experienced by at least 25% of patients, including laboratory abnormalities, included decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%) and decreased sodium (26%).

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AZ Gets EU Okay For Tagrisso In Early-stage Lung Cancer

News

Tero

AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU as a treatment for a specific form of locally advanced, unresectable non-small cell lung cancer (NSCLC).

The European Commission has approved Tagrisso (osimertinib) for this indication in patients with stage 3 tumours that have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT).

The highly anticipated approval comes on the back of the LAURA trial, which was a highlight of this year's ASCO congress and has been tipped to become an important new indication for Tagrisso, currently AZ's second best-selling drug, with sales of almost $4.9 billion in the first nine months of this year.

The results showed that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with progression-free survival (PFS) of 39.1 months and 5.6 months, respectively.

At ASCO, the stellar PFS data sparked speculation that Tagrisso will become the standard of care in this type of early lung cancer, which until now had no targeted therapies approved in the EU. The drug was approved in the US for the same indication in September.

AZ has previously said that the LAURA results, combined with the ADAURA study of Tagrisso as adjuvant treatment of EGFR-positive NSCLC, which was a highlight of the 2023 ASCO conference, show that EGFR inhibitors can have a dramatic impact in early-stage lung cancer and should be used as early as possible in the treatment pathway.

That's important for AZ, as Tagrisso is starting to face the threat of competition from other EGFR drugs, including Johnson & Johnson's fast-growing EGFRxMET bispecific antibody Rybrevant (amivantamab), which has previously been tipped as a future $5 billion-a-year product, although a recent FDA complete response letter has tarnished its lustre.

The head of AZ's oncology business unit, Dave Fredrickson, said that the LAURA results and Tagrisso approval "reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy" for EGFR-mutated NSCLC, spanning early to late-metastatic settings.

"Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy," he added.

Tagrisso is already approved for patients with EGFR mutations in the frontline metastatic setting, both as a monotherapy and in combination with chemotherapy and as an adjuvant treatment for early-stage disease, but AZ has said that new studies like the LAURA trial will be "excellent growth drivers."

Earlier this year, the drug also showed its potential as an all-oral therapy alongside AZ's cMET inhibitor Orpathys (savolitinib) in the SAVANNAH trial involving patients with EGFR-mutated NSCLC that has progressed after earlier Tagrisso therapy. The confirmatory SAFFRON study in that indication is due to read out next year.

Image by Tero from Pixabay

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