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Gilead (GILD) Down as NSCLC Study Fails to Meet Primary Goal
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Shares of Gilead Sciences, Inc. (GILD - Free Report) were down 10.15% after it announced that the late-stage study evaluating oncology drug Trodelvy (sacituzumab govitecan) in previously treated metastatic non-small cell lung cancer (“NSCLC”) failed.
The phase III study, EVOKE-01, evaluated Trodelvy vis-à-vis docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants who were randomized equally in both arms.
The study did not meet its primary endpoint of overall survival (“OS”), even though a numerical improvement in OS favoring sacituzumab govitecan was observed in the study in patients with both squamous and non-squamous histology.
Data further showed a difference of more than three months in median OS favoring sacituzumab govitecan in a sub-group of patients non-responsive to the last prior anti-PD-(L)1 therapy. These patients represented more than 60% of the trial population. This analysis was pre-specified in the protocol but not alpha-controlled for formal statistical testing. However, this magnitude of difference was not observed in the sub-group of patients with response to the last prior anti-PD-(L)1 therapy.
Gilead’s acquisition of Immunomedics added Trodelvy, a first-in-class antibody-drug conjugate (“ADC”), to its portfolio.
We note that Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Trodelvy is also approved in the United States and the European Union to treat patients with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy has also obtained accelerated approval for treating patients with second-line metastatic urothelial cancer in the United States.
Trodelvy's performance has been outstanding since its approval and the drug is driving Gilead's efforts to build a strong oncology franchise, especially given the current focus on ADCs.
The results of the EVOKE-01 study in the lucrative NSCLC indication were a setback and disappointed investors. NSCLC is the most common form of lung cancer.
Shares of Gilead have gained 1% in the past six months against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
Nevertheless, GILD is currently evaluating Trodelvy for the NSCLC indication in multiple ongoing registrational phase III studies and several ongoing phase II studies.
The phase II 2 EVOKE-02 study of Trodelvy in combination with Keytruda showed strong preliminary efficacy and safety data. Hence, Gilead remains confident in its ongoing phase III EVOKE-03 study in 1L metastatic PD-L1 high NSCLC patients, which is currently enrolling. In addition, Gilead has a broad clinical development program in lung cancer with domvanalimab, the first Fc-silent investigational anti-TIGIT antibody.
ADCs are in the spotlight in the pharma/biotech sector.
We remind investors that, in November 2023, AbbVie Inc. (ABBV - Free Report) announced that it would acquire ImmunoGen, Inc. and add Immunogen’s flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx), a first-in-class ADC approved for platinum-resistant ovarian cancer, to its portfolio.
ImmunoGen's follow-on pipeline of promising next-generation ADCs further complements AbbVie's ADC platform and existing programs.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. REGN’s stock has gained 29.6% in the past year. The company beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.
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Gilead (GILD) Down as NSCLC Study Fails to Meet Primary Goal
Shares of Gilead Sciences, Inc. (GILD - Free Report) were down 10.15% after it announced that the late-stage study evaluating oncology drug Trodelvy (sacituzumab govitecan) in previously treated metastatic non-small cell lung cancer (“NSCLC”) failed.
The phase III study, EVOKE-01, evaluated Trodelvy vis-à-vis docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants who were randomized equally in both arms.
The study did not meet its primary endpoint of overall survival (“OS”), even though a numerical improvement in OS favoring sacituzumab govitecan was observed in the study in patients with both squamous and non-squamous histology.
Data further showed a difference of more than three months in median OS favoring sacituzumab govitecan in a sub-group of patients non-responsive to the last prior anti-PD-(L)1 therapy. These patients represented more than 60% of the trial population. This analysis was pre-specified in the protocol but not alpha-controlled for formal statistical testing. However, this magnitude of difference was not observed in the sub-group of patients with response to the last prior anti-PD-(L)1 therapy.
Gilead’s acquisition of Immunomedics added Trodelvy, a first-in-class antibody-drug conjugate (“ADC”), to its portfolio.
We note that Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Trodelvy is also approved in the United States and the European Union to treat patients with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy has also obtained accelerated approval for treating patients with second-line metastatic urothelial cancer in the United States.
Trodelvy's performance has been outstanding since its approval and the drug is driving Gilead's efforts to build a strong oncology franchise, especially given the current focus on ADCs.
The results of the EVOKE-01 study in the lucrative NSCLC indication were a setback and disappointed investors. NSCLC is the most common form of lung cancer.
Shares of Gilead have gained 1% in the past six months against the industry’s decline of 0.6%.
Image Source: Zacks Investment Research
Nevertheless, GILD is currently evaluating Trodelvy for the NSCLC indication in multiple ongoing registrational phase III studies and several ongoing phase II studies.
The phase II 2 EVOKE-02 study of Trodelvy in combination with Keytruda showed strong preliminary efficacy and safety data. Hence, Gilead remains confident in its ongoing phase III EVOKE-03 study in 1L metastatic PD-L1 high NSCLC patients, which is currently enrolling. In addition, Gilead has a broad clinical development program in lung cancer with domvanalimab, the first Fc-silent investigational anti-TIGIT antibody.
ADCs are in the spotlight in the pharma/biotech sector.
We remind investors that, in November 2023, AbbVie Inc. (ABBV - Free Report) announced that it would acquire ImmunoGen, Inc. and add Immunogen’s flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx), a first-in-class ADC approved for platinum-resistant ovarian cancer, to its portfolio.
ImmunoGen's follow-on pipeline of promising next-generation ADCs further complements AbbVie's ADC platform and existing programs.
Zacks Rank and Stock to Consider
Gilead currently has a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Regeneron Pharmaceuticals (REGN - Free Report) , which presently has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. REGN’s stock has gained 29.6% in the past year. The company beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.