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GSK Presents Jideytro Data for Potential Use in First-Line NSCLC
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Key Takeaways
Jideytro achieved a 94% response rate in first-line ROS1-positive NSCLC patients.
GSK reported 90% of patients remained progression-free at 12 months.
About 70% of patients with measurable brain metastases achieved complete tumor clearance.
GSK plc (GSK - Free Report) announced positive data from the registrational phase I/II ARROS-1 study evaluating its oncology drug, Jideytro (zidesamtinib), for the first-line treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Jideytro is a next-generation, highly selective ROS1 inhibitor that is already approved for previously treated ROS1-positive NSCLC.
The drug was added to GSK’s oncology portfolio as a late-stage candidate through the recent acquisition ofNuvalent.
Year to date, GSK’s shares have lost 1.9% against the industry’s 5.2% growth.
Image Source: Zacks Investment Research
Details of GSK’s ARROS-1 Study in First-Line NSCLC
The global phase I/II ARROS-1 study evaluated Jideytro in 94 patients with advanced or metastatic ROS1-positive NSCLC who had not previously received a ROS1 tyrosine kinase inhibitor (TKI).
Jideytro demonstrated a 94% objective response rate, with 15% of patients achieving a complete response after a median follow-up of 15.2 months. The treatment also showed durable disease control, with 90% of patients remaining progression-free at 12 months, while median progression-free survival (PFS) had not yet been reached.
The study also reported durable clinical responses, including in patients with measurable brain metastases. Approximately 70% of patients with measurable brain metastases achieved complete clearance of detectable brain tumors.
Jideytro was generally well-tolerated, with low rates of treatment discontinuation consistent with previously reported safety results. The most commonly reported adverse events included peripheral edema, weight gain, increased blood creatine phosphokinase levels, dysgeusia and increased aspartate aminotransferase levels.
GSK presented these data at a medical conference in South Korea. The study data are expected to support GSK’s planned supplemental new drug application to the FDA later this year seeking approval to expand Jideytro’s use in first-line lung cancer.
The Nuvalent acquisition strengthened GSK's growing oncology business by adding a portfolio of targeted therapies for genetically defined forms of NSCLC.
Beyond Jideytro, GSK's acquired pipeline includes neladalkib, an investigational ALK inhibitor currently under FDA review, with a PDUFA target date of Nov. 27, 2026, and NVL-330, a HER2-targeted therapy that is being evaluated in phase I studies for HER2-altered NSCLC.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 63.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 12.1% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 74.2% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
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GSK Presents Jideytro Data for Potential Use in First-Line NSCLC
Key Takeaways
GSK plc (GSK - Free Report) announced positive data from the registrational phase I/II ARROS-1 study evaluating its oncology drug, Jideytro (zidesamtinib), for the first-line treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Jideytro is a next-generation, highly selective ROS1 inhibitor that is already approved for previously treated ROS1-positive NSCLC.
The drug was added to GSK’s oncology portfolio as a late-stage candidate through the recent acquisition ofNuvalent.
Year to date, GSK’s shares have lost 1.9% against the industry’s 5.2% growth.
Image Source: Zacks Investment Research
Details of GSK’s ARROS-1 Study in First-Line NSCLC
The global phase I/II ARROS-1 study evaluated Jideytro in 94 patients with advanced or metastatic ROS1-positive NSCLC who had not previously received a ROS1 tyrosine kinase inhibitor (TKI).
Jideytro demonstrated a 94% objective response rate, with 15% of patients achieving a complete response after a median follow-up of 15.2 months. The treatment also showed durable disease control, with 90% of patients remaining progression-free at 12 months, while median progression-free survival (PFS) had not yet been reached.
The study also reported durable clinical responses, including in patients with measurable brain metastases. Approximately 70% of patients with measurable brain metastases achieved complete clearance of detectable brain tumors.
Jideytro was generally well-tolerated, with low rates of treatment discontinuation consistent with previously reported safety results. The most commonly reported adverse events included peripheral edema, weight gain, increased blood creatine phosphokinase levels, dysgeusia and increased aspartate aminotransferase levels.
GSK presented these data at a medical conference in South Korea. The study data are expected to support GSK’s planned supplemental new drug application to the FDA later this year seeking approval to expand Jideytro’s use in first-line lung cancer.
Nuvalent Acquisition Boosts GSK's Precision Oncology Franchise
The Nuvalent acquisition strengthened GSK's growing oncology business by adding a portfolio of targeted therapies for genetically defined forms of NSCLC.
Beyond Jideytro, GSK's acquired pipeline includes neladalkib, an investigational ALK inhibitor currently under FDA review, with a PDUFA target date of Nov. 27, 2026, and NVL-330, a HER2-targeted therapy that is being evaluated in phase I studies for HER2-altered NSCLC.
GSK’s Zacks Rank & Stock to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 63.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 12.1% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 74.2% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.