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Merck, Daiichi Withdraw FDA Filing for Lung Cancer Therapy
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Key Takeaways
Merck and Daiichi withdrew the FDA filing for ifinatamab deruxtecan in relapsed ES-SCLC.
FDA discussions found available data did not support accelerated approval for the ADC candidate.
Enrollment nears completion in phase III IDeate-Lung02, which could support a future filing.
Merck (MRK - Free Report) and partner Daiichi Sankyo announced that they have voluntarily withdrawn a regulatory filing with the FDA seeking accelerated approval for an investigational antibody-drug conjugate (ADC) called ifinatamab deruxtecan in lung cancer.
The companies were seeking approval for the ADC candidate to treat adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Why Did Merck & Daiichi Withdraw the Filing?
The decision was based on discussions with the FDA, which indicated that the available data — including results from the phase II IDeate-Lung01 study — did not satisfy the requirements needed to support accelerated approval.
However, the companies continue to evaluate ifinatamab deruxtecan in ES-SCLC. Patient enrollment is nearing completion in the phase III IDeate-Lung02 study, which compares the ADC with physician’s-choice chemotherapy in patients with relapsed ES-SCLC after one prior line of platinum-based chemotherapy.
The companies could use data from this late-stage study to support a future regulatory filing for ifinatamab deruxtecan with the FDA and other global health authorities, depending on the results. Merck and Daiichi Sankyo are also evaluating the ADC in two additional late-stage studies for castration-resistant prostate cancer (CRPC) and esophageal squamous cell carcinoma (ESCC).
MRK’s Stock Performance
The company’s shares have risen 41% year-to-date compared with the industry’s 13% growth.
Image Source: Zacks Investment Research
Another Blow to Merck’s Daiichi Sankyo Partnership
Ifinatamab deruxtecan is being co-developed by Merck and Daiichi as part of an agreement signed in 2023. This deal also involved two other ADCs, namely patritumab deruxtecan and raludotatug deruxtecan.
Notably, this is the second candidate being developed under the agreement that was voluntarily withdrawn. Last year, Merck and Daiichi voluntarily withdrew a filing with the FDA for patritumab to treat certain previously-treated adult patients with advanced non-small cell lung cancer (NSCLC). The filing had originally been submitted seeking accelerated approval based on results from the phase II HERTHENA-Lung01 study. However, the companies subsequently withdrew the submission after top-line overall survival results from the confirmatory phase III HERTHENA-Lung02 study failed to achieve statistical significance, following discussions with the FDA.
The latest setback could create an opportunity for competing ADCs being developed by GSK plc (GSK - Free Report) and Roche (RHHBY - Free Report) . Earlier this month, GSK’s risvutatug rezetecan (ris-rez) and Roche’s tambotatug pelitecan (tam-peli) delivered positive phase III results in relapsed SCLC in China. Ris-rez reduced the risk of death by 54% versus topotecan (a chemotherapy drug) in the ARTEMIS-008 study, while tam-peli achieved a similar 54% reduction in the risk of death versus topotecan in the TAISHAN-302 study.
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Merck, Daiichi Withdraw FDA Filing for Lung Cancer Therapy
Key Takeaways
Merck (MRK - Free Report) and partner Daiichi Sankyo announced that they have voluntarily withdrawn a regulatory filing with the FDA seeking accelerated approval for an investigational antibody-drug conjugate (ADC) called ifinatamab deruxtecan in lung cancer.
The companies were seeking approval for the ADC candidate to treat adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Why Did Merck & Daiichi Withdraw the Filing?
The decision was based on discussions with the FDA, which indicated that the available data — including results from the phase II IDeate-Lung01 study — did not satisfy the requirements needed to support accelerated approval.
However, the companies continue to evaluate ifinatamab deruxtecan in ES-SCLC. Patient enrollment is nearing completion in the phase III IDeate-Lung02 study, which compares the ADC with physician’s-choice chemotherapy in patients with relapsed ES-SCLC after one prior line of platinum-based chemotherapy.
The companies could use data from this late-stage study to support a future regulatory filing for ifinatamab deruxtecan with the FDA and other global health authorities, depending on the results. Merck and Daiichi Sankyo are also evaluating the ADC in two additional late-stage studies for castration-resistant prostate cancer (CRPC) and esophageal squamous cell carcinoma (ESCC).
MRK’s Stock Performance
The company’s shares have risen 41% year-to-date compared with the industry’s 13% growth.
Image Source: Zacks Investment Research
Another Blow to Merck’s Daiichi Sankyo Partnership
Ifinatamab deruxtecan is being co-developed by Merck and Daiichi as part of an agreement signed in 2023. This deal also involved two other ADCs, namely patritumab deruxtecan and raludotatug deruxtecan.
Notably, this is the second candidate being developed under the agreement that was voluntarily withdrawn. Last year, Merck and Daiichi voluntarily withdrew a filing with the FDA for patritumab to treat certain previously-treated adult patients with advanced non-small cell lung cancer (NSCLC). The filing had originally been submitted seeking accelerated approval based on results from the phase II HERTHENA-Lung01 study. However, the companies subsequently withdrew the submission after top-line overall survival results from the confirmatory phase III HERTHENA-Lung02 study failed to achieve statistical significance, following discussions with the FDA.
The latest setback could create an opportunity for competing ADCs being developed by GSK plc (GSK - Free Report) and Roche (RHHBY - Free Report) . Earlier this month, GSK’s risvutatug rezetecan (ris-rez) and Roche’s tambotatug pelitecan (tam-peli) delivered positive phase III results in relapsed SCLC in China. Ris-rez reduced the risk of death by 54% versus topotecan (a chemotherapy drug) in the ARTEMIS-008 study, while tam-peli achieved a similar 54% reduction in the risk of death versus topotecan in the TAISHAN-302 study.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
MRK’s Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.