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AZN's Tagrisso Plus Orpathys Study in First-Line NSCLC Meets Goal
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Key Takeaways
AstraZeneca's SANOVO study showed a significant PFS improvement with Tagrisso plus Orpathys.
The combination improved PFS in both high-MET and broader MET overexpression populations.
AstraZeneca reported encouraging OS improvements, with follow-up ongoing for mature data.
AstraZeneca (AZN - Free Report) announced positive data from the phase III SANOVO study evaluating Tagrisso (osimertinib) plus Orpathys (savolitinib) in treatment-naïve patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.
The study is being conducted by HUTCHMED, AZN’s partner. In 2011, both companies entered into a global licensing and collaboration agreement to jointly develop Orpathys. HUTCHMED leads the development of Orpathys in China, while AstraZeneca leads development outside China. AstraZeneca is responsible for commercialization of the drug in China and worldwide.
Tagrisso plus Orpathys is approved in China for patients with advanced EGFR-mutated NSCLC whose disease has progressed following EGFR-TKI treatment and whose tumors harbor MET amplification. The positive SANOVO results could expand the clinical utility of the combination by supporting its use in the first-line setting.
Year to date, AZN’s shares have lost 11.7% against the industry’s 8.7% growth.
Image Source: Zacks Investment Research
Key Highlights of Phase III AZN/ HUTCHMED’s SANOVO Study
The phase III SANOVO study demonstrated that treatment with Tagrisso plus Orpathys led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus Tagrisso monotherapy in treatment-naïve patients with EGFR-mutated advanced or metastatic NSCLC and MET overexpression. The PFS benefit was observed in both high-MET (IHC 3+) and the broader intention-to-treat (IHC 2+/3+) populations. The combination also demonstrated encouraging improvements in overall survival (OS), although the study continues to follow patients for further maturation of the data.
The safety profile of the SANOVO study was consistent with the known profiles of both medicines, with no new safety concerns, and the data will be presented at a forthcoming medical meeting and shared with regulators.
SANOVO Results Build on SACHI & SAFFRON Success
The positive SANOVO results extend the clinical evidence generated by the SACHI and global SAFFRON studies. Previously, the phase III SACHI study established the benefit of Tagrisso plus Orpathys in previously treated EGFR-mutated NSCLC with MET amplification in China. Data from the late-stage SAFFRON study announced in August demonstrated that Tagrisso plus Orpathys led to a statistically significant and clinically meaningful improvement in PFS and OS versus platinum-based chemotherapy in patients with EGFR-mutated NSCLC whose tumors had high MET overexpression or amplification and whose disease had progressed following Tagrisso treatment.
More on AZN’s Tagrisso & Orpathys
Tagrisso remains a key growth driver for AstraZeneca and is marketed globally for EGFR-mutated NSCLC across multiple treatment settings. The expanding clinical evidence for Tagrisso in combination with Orpathys could provide an additional avenue for extending its value in the EGFR-mutated NSCLC market.
Orpathys is approved in certain patients with locally advanced or metastatic NSCLC and holds conditional approval for gastric cancer in China.
Over the past 30 days, estimates for Precigen’s 2026 loss per share 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's shares have risen 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 30 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 have remained unchanged at 17 cents. ACIU shares have lost 14.7% 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 30 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's shares have plunged 71.3% 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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AZN's Tagrisso Plus Orpathys Study in First-Line NSCLC Meets Goal
Key Takeaways
AstraZeneca (AZN - Free Report) announced positive data from the phase III SANOVO study evaluating Tagrisso (osimertinib) plus Orpathys (savolitinib) in treatment-naïve patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.
The study is being conducted by HUTCHMED, AZN’s partner. In 2011, both companies entered into a global licensing and collaboration agreement to jointly develop Orpathys. HUTCHMED leads the development of Orpathys in China, while AstraZeneca leads development outside China. AstraZeneca is responsible for commercialization of the drug in China and worldwide.
Tagrisso plus Orpathys is approved in China for patients with advanced EGFR-mutated NSCLC whose disease has progressed following EGFR-TKI treatment and whose tumors harbor MET amplification. The positive SANOVO results could expand the clinical utility of the combination by supporting its use in the first-line setting.
Year to date, AZN’s shares have lost 11.7% against the industry’s 8.7% growth.
Image Source: Zacks Investment Research
Key Highlights of Phase III AZN/ HUTCHMED’s SANOVO Study
The phase III SANOVO study demonstrated that treatment with Tagrisso plus Orpathys led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus Tagrisso monotherapy in treatment-naïve patients with EGFR-mutated advanced or metastatic NSCLC and MET overexpression. The PFS benefit was observed in both high-MET (IHC 3+) and the broader intention-to-treat (IHC 2+/3+) populations. The combination also demonstrated encouraging improvements in overall survival (OS), although the study continues to follow patients for further maturation of the data.
The safety profile of the SANOVO study was consistent with the known profiles of both medicines, with no new safety concerns, and the data will be presented at a forthcoming medical meeting and shared with regulators.
SANOVO Results Build on SACHI & SAFFRON Success
The positive SANOVO results extend the clinical evidence generated by the SACHI and global SAFFRON studies. Previously, the phase III SACHI study established the benefit of Tagrisso plus Orpathys in previously treated EGFR-mutated NSCLC with MET amplification in China. Data from the late-stage SAFFRON study announced in August demonstrated that Tagrisso plus Orpathys led to a statistically significant and clinically meaningful improvement in PFS and OS versus platinum-based chemotherapy in patients with EGFR-mutated NSCLC whose tumors had high MET overexpression or amplification and whose disease had progressed following Tagrisso treatment.
More on AZN’s Tagrisso & Orpathys
Tagrisso remains a key growth driver for AstraZeneca and is marketed globally for EGFR-mutated NSCLC across multiple treatment settings. The expanding clinical evidence for Tagrisso in combination with Orpathys could provide an additional avenue for extending its value in the EGFR-mutated NSCLC market.
Orpathys is approved in certain patients with locally advanced or metastatic NSCLC and holds conditional approval for gastric cancer in China.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Precigen’s 2026 loss per share 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's shares have risen 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 30 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 have remained unchanged at 17 cents. ACIU shares have lost 14.7% 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 30 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's shares have plunged 71.3% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.