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Jazz (JAZZ) Gastric Cancer Study Shows Improved Overall Survival
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Jazz Pharmaceuticals (JAZZ - Free Report) along with partner Zymeworks (ZYME - Free Report) announced positive tolerability and efficacy results from an ongoing phase II study on zanidatamab, an investigational HER2-targeted bispecific antibody, in HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA).
The phase II study is evaluating zanidatamab plus chemotherapy as a first-line treatment for patients with advanced HER2-expressing mGEA, comprising gastric, esophageal and gastroesophageal junction (GEJ) patients.
Data from the study demonstrated showed that the combination of zanidatamab and chemotherapy is a highly active treatment regimen for first-line therapy of HER2-positive mGEA. Among patients evaluable for OS who received this combination, the overall survival (OS) rate was 84% at 18 months. Data from this study also showed that treatment with zanidatamab achieved an overall confirmed objective response rate (cORR) of 79% and a disease control rate (DCR) of 92%.
In fact, the median OS is yet to be reached at a median duration of study follow-up and the median progression-free survival of 26.5 months and 12.5 months, respectively.
The above results exhibit the potential of zanidatamab in treating HER2-positive mGEA patients. These results also support the ongoing pivotal phase III HERIZON-GEA-01 study evaluating the combination of zanidatamab and chemotherapy, with or without BeiGene‘s (BGNE - Free Report) investigational anti-PD-1 monoclonal antibody tislelizumab, as a first-line treatment for HER2-expressing mGEA. Data from this pivotal late-stage study, which is expected next year, will support the regulatory filings for zanidatamab in HER2-positive mGEA with the FDA and other regulatory authorities.
Shares of Jazz have gained 12.2% in the year against the industry’s 15.6% decline.
Image Source: Zacks Investment Research
Per management, gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer in the world. Currently, around 20% of GEA patients are HER2–positive, with high morbidity and mortality. Patients with HER2-positive GEA are urgently in need of new treatment options.
Developed by Zymeworks, Zanidatamab is an investigational antibody candidate that has been designed as a treatment option for patients with solid tumors that express HER2. The candidate is being evaluated by ZYME in multiple clinical studies targeting multiple oncology indications.
Last month, Jazz Pharmaceuticals exercised an option under the recently entered collaboration agreement for licensing rights to zanidatamab, which is also Zymeworks’ lead candidate.
Following the exercise of this option, Jazz will now hold exclusive development and commercialization rights to zanidatamab across all its indications in all territories except in Asia/Pacific territories where the drug has already been licensed to BeiGene. In consideration for exercising the option, Zymeworks became eligible to receive an upfront payment of $325 million from Jazz.
Zymeworks entered into a strategic collaboration with BeiGene in 2018, where the latter acquired the exclusive rights to develop and commercialize zanidatamab and zanidatamab zovodotin (ZW49) in Asia (excluding Japan), Australia and New Zealand. In return, ZYME received $40 million as an upfront payment from BeiGene. In addition, Zymeworks will also be entitled to receive development and commercial milestone payments of up to $390 million from BeiGene and potential royalties on future product sales.
In the past 60 days, estimates for Allogene’s 2023 loss per share have narrowed from $2.84 to $2.82. Shares of Allogene have declined 45.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.
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Jazz (JAZZ) Gastric Cancer Study Shows Improved Overall Survival
Jazz Pharmaceuticals (JAZZ - Free Report) along with partner Zymeworks (ZYME - Free Report) announced positive tolerability and efficacy results from an ongoing phase II study on zanidatamab, an investigational HER2-targeted bispecific antibody, in HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA).
The phase II study is evaluating zanidatamab plus chemotherapy as a first-line treatment for patients with advanced HER2-expressing mGEA, comprising gastric, esophageal and gastroesophageal junction (GEJ) patients.
Data from the study demonstrated showed that the combination of zanidatamab and chemotherapy is a highly active treatment regimen for first-line therapy of HER2-positive mGEA. Among patients evaluable for OS who received this combination, the overall survival (OS) rate was 84% at 18 months. Data from this study also showed that treatment with zanidatamab achieved an overall confirmed objective response rate (cORR) of 79% and a disease control rate (DCR) of 92%.
In fact, the median OS is yet to be reached at a median duration of study follow-up and the median progression-free survival of 26.5 months and 12.5 months, respectively.
The above results exhibit the potential of zanidatamab in treating HER2-positive mGEA patients. These results also support the ongoing pivotal phase III HERIZON-GEA-01 study evaluating the combination of zanidatamab and chemotherapy, with or without BeiGene‘s (BGNE - Free Report) investigational anti-PD-1 monoclonal antibody tislelizumab, as a first-line treatment for HER2-expressing mGEA. Data from this pivotal late-stage study, which is expected next year, will support the regulatory filings for zanidatamab in HER2-positive mGEA with the FDA and other regulatory authorities.
Shares of Jazz have gained 12.2% in the year against the industry’s 15.6% decline.
Image Source: Zacks Investment Research
Per management, gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer in the world. Currently, around 20% of GEA patients are HER2–positive, with high morbidity and mortality. Patients with HER2-positive GEA are urgently in need of new treatment options.
Developed by Zymeworks, Zanidatamab is an investigational antibody candidate that has been designed as a treatment option for patients with solid tumors that express HER2. The candidate is being evaluated by ZYME in multiple clinical studies targeting multiple oncology indications.
Last month, Jazz Pharmaceuticals exercised an option under the recently entered collaboration agreement for licensing rights to zanidatamab, which is also Zymeworks’ lead candidate.
Following the exercise of this option, Jazz will now hold exclusive development and commercialization rights to zanidatamab across all its indications in all territories except in Asia/Pacific territories where the drug has already been licensed to BeiGene. In consideration for exercising the option, Zymeworks became eligible to receive an upfront payment of $325 million from Jazz.
Zymeworks entered into a strategic collaboration with BeiGene in 2018, where the latter acquired the exclusive rights to develop and commercialize zanidatamab and zanidatamab zovodotin (ZW49) in Asia (excluding Japan), Australia and New Zealand. In return, ZYME received $40 million as an upfront payment from BeiGene. In addition, Zymeworks will also be entitled to receive development and commercial milestone payments of up to $390 million from BeiGene and potential royalties on future product sales.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stock to Consider
Jazz currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Allogene (ALLO - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Allogene’s 2023 loss per share have narrowed from $2.84 to $2.82. Shares of Allogene have declined 45.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.