A combination therapy of Jazz Pharmaceutical’s Zepzelca (lurbinectedin) and Roche’s Tecentriq (atezolizumab) has gained US Food and Drug Administration (FDA) approval in an agressive form of lung cancer.
Following the FDA’s decision, the combo duo will be available as a maintenance therapy to patients with extensive-stage small cell lung cancer (ES-SCLC).
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The approval, which covers intravenous and subcutaneous forms of Tecentriq, will mean patients who have not progressed after first-line treatment will now have a dual therapy option.
The FDA’s approval of Tecentriq-Zepzelca follows positive results from the Phase III IMforte trial (NCT05091567), which found that the two drugs could reduce the risk of disease progression or death by 46% compared with Tecentriq alone.
Tecentriq has been a significant driver of the ES-SCLC market, gaining approval as a first-line treatment in 2019. According to analysts at GlobalData, Roche’s programmed death ligand 1 (PD-L1) inhibitor is forecast to generate around $4.1bn annually until 2029.
GlobalData is the parent company of Pharmaceutical Technology.
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By GlobalDataAdding Jazz’s asset to Tecentriq also demonstrated a favourable impact on overall survival (OS), leading to 13.2 months compared with the 10.6 months produced by Tecentriq alone.
Through this approval, Tecentriq-Zepzelca becomes the first and only maintenance therapy to secure FDA clearance to treat ES-SCLC, bolstering the range of available therapeutic options.
However, the two pharma companies will still have to overcome AstraZeneca’s Imfinzi (durvalumab) in the maintenance setting, as the blockbuster drug is also recommended on the National Comprehensive Cancer Network (NCCN)’s SCLC clinical practice guidelines.
Despite this, Tecentriq-Zepzelca marginally bests its rival in terms of OS, with Imfinzi boosting OS by 13 months in the CASPIAN trial (NCT03043872). It is important to note that no comparative study between Tecentriq-Zepzelca and Imfinzi in the maintenance setting has been performed, so this comparison is not certain.
Zepzelca obtains first full approval
The FDA’s appproval of Tecentriq-Zepzelca will also be welcome news for Jazz Pharmaceuticals, which had not yet received the full go-ahead for Zepzelca in ES-SCLC following its accelerated authorisation in 2022.
GlobalData oncology and haematology analyst Biswajit Podder said: “This approval moves Zepzelca from second line to routine first-line maintenance, expanding its treated population.”
However, despite the drug’s uptake being supported by guideline changes and reimbursements, Podder notes that Zepzelca’s total boost in sales is “bounded by the rare nature of ES-SCLC”, as well as its confinement to non-progressors only.
Despite this, analysts at GlobalData forecast that the drug will reach blockbuster status in 2030, pulling in $1.1bn by 2031.
Meanwhile, Podder stated that the approval will “expand Tecentriq’s maintenance duration, while defending its share in Tecentriq-using cancer centres”.
Though he predicts that Tecentriq and Zepzelca will become the go-to options in patients who started on the former drug and didn’t progress, he notes that it will “not replace durvalumab pathways without comparative data”.
In terms of patient outcomes, Podder believes that the integration of Tecentriq-Zepzelca into the maintenance paradigm alongside routine blood count monitoring to manage added myelosuppression should “translate into longer disease control and improved outcomes for eligible ES-SCLC patients”.
