JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)

Start Date30 Jul 2026

Sponsor / Collaborator-

NCT07586202

/ RecruitingPhase 2

A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

Start Date28 Jul 2026

Sponsor / Collaborator

Janssen Research & Development LLC

KCT0012047

/ Not yet recruitingPhase 2IIT

A Randomized study to evaluate the efficacy of reduced starting dose of Lazertinib(Leclaza) and preemptive magnesium supplement to prevent Lazertinib(Leclaza) induced peripheral neuropathy

Start Date30 Jun 2026

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Lazertinib Mesylate

100 Translational Medicine associated with Lazertinib Mesylate

100 Patents (Medical) associated with Lazertinib Mesylate

198

Literatures (Medical) associated with Lazertinib Mesylate

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer

Article

Author: Upton, Elysia ; Hearmon, Natalie ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh

OBJECTIVES:

Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.

METHODS:

A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.

RESULTS:

The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.

LIMITATIONS:

Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.

CONCLUSIONS:

From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.

01 Nov 2026·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

Molecular modeling study on the binding mechanisms of third-generation EGFR inhibitor Lazertinib

Article

Author: Wu, Xiaoyun ; Wei, Yongbo ; He, Huan

In recent years, in the treatment of non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) inhibitors have demonstrated ideal clinical efficacy. Unfortunately, a significant obstacle to targeted lung cancer therapy is the unavoidable emergence of acquired resistance to EGFR inhibitors through a variety of pathways during a period of medication. The third-generation EGFR inhibitor Lazertinib, which is potent, irreversible, brain-penetrant, mutant-selective, and wild type-sparing, was used to treat patients with advanced or metastatic NSCLC. Lazertinib can bind to EGFR^T790M in different conformations, identified by a 180° rotation of the pyrazole moiety, according to the X-ray co-crystal structure. A molecular modeling study integrating molecular dynamics and free energy calculation was conducted to comprehend the distinct binding manner of Lazertinib binding to EGFR and the structural need for the inhibitory activity. According to binding free energy calculations, Lazertinib has a greater binding affinity with EGFR^T790M than EGFR^WT, which is in accordance with the experimental observations. Additionally, it confirms that Lazertinib preferentially binds to EGFR^T790M with the same conformation as in EGFR^WT. The residues that made a greater contribution to the binding of Lazertinib to EGFR were identified using the per-residue energy decomposition. It is anticipated that these findings will be helpful to the rational development of new EGFR inhibitors.

15 Oct 2026·Cancer Research and Treatment

Preferential Sensitivity of the EGFR L858M/L861R Mutation to Second-Generation EGFR Tyrosine Kinase Inhibitors in Non–Small Cell Lung Cancer

Article

Author: Kim, Dong-Wan ; Kim, Sheehyun ; Kim, Soyeon ; Youk, Jeonghwan ; Park, Taekeun ; Kim, Miso ; Lee, Chaelin ; Kim, Tae Min ; Keam, Bhumsuk

Purpose Non–small cell lung cancer (NSCLC) frequently harbors targetable epidermal growth factor receptor (EGFR) mutations. However, rare variants such as EGFR L858M or L861R remain poorly characterized. This study aimed to elucidate the oncogenic potential and EGFR tyrosine kinase inhibitors (TKIs) sensitivity of the EGFR L858M/L861R mutation to inform personalized treatment strategies.Materials and Methods Tumor samples from an NSCLC patient were analyzed using targeted panel sequencing and confirmed with the FoundationOne Liquid CDx assay. EGFR-mutant constructs, including L858M, L858R, L861R, L861Q, L858M/L861R, and L858R/L861Q, were generated and transduced into various cell lines. Cell viability, immunoblot, and soft agar colony formation assays were conducted to assess the oncogenicity and drug sensitivity, while computational protein modeling and docking simulations evaluated the drug-binding affinities of EGFR-TKIs.Results Ba/F3 cells expressing the EGFR L858M/L861R mutation exhibited robust interleukin-3–independent proliferation accompanied by markedly increased EGFR phosphorylation, while NIH-3T3 cells showed anchorage-independent colony formation. Compared to other mutations, cells expressing EGFR L858M/L861R mutation were less sensitive to first-generation EGFR-TKIs (gefitinib, erlotinib) and third-generation EGFR-TKIs (osimertinib, lazertinib), whereas second-generation EGFR-TKIs (afatinib, poziotinib) demonstrated potent inhibitory effects. Computational modeling revealed a narrower drug-binding efficiency of first-generation inhibitors.Conclusion The EGFR L858M/L861R mutation drives strong oncogenic signaling and exhibits preferential sensitivity to second-generation EGFR-TKIs. These findings underscore the importance of accurate molecular diagnosis for guiding effective, personalized therapeutic strategies in NSCLC.

223

News (Medical) associated with Lazertinib Mesylate

13 Oct 2026

·www.mddionline.com

J&J Inches Closer to $100 Billion… Will a Medtech Stumble Cloud the Story?

Johnson & Johnson delivered a third-quarter performance on October 13, 2026, that told two very different stories depending on which part of the business you were watching. The pharmaceutical arm, now branded Innovative Medicine, continued its hot streak, while the medical device business once again fell short of where the company wanted it to be. Investors clearly noticed the split. Despite revenue coming in ahead of expectations, J&J shares slipped as much as 4.36% following the announcement, suggesting Wall Street cared more about where the cracks are than where the growth is. The headline numbers were respectable on their face. The company posted $25.4 billion in quarterly revenue, edging past analyst expectations of roughly $25.28 billion, while adjusted earnings of $2.59 per share also topped the consensus estimate of around $2.54. J&J used the results as an opportunity to raise its full-year guidance once again, nudging its reported sales outlook up to a range of $101 billion to $101.4 billion and lifting its adjusted earnings forecast to a midpoint of $11.10 per share. That revenue trajectory would mark a milestone the company has never hit in its 140-year history: crossing the $100 billion mark in annual sales. Still, the quarter wasn't without pain. Reported net earnings cratered to just $210 million, or nine cents per diluted share, a steep drop from the $5.15 billion the company posted in the same period a year earlier. That decline wasn't a sign of operational trouble, but rather the result of roughly $7 billion in special charges tied to talc litigation and recent acquisitions, including Firefly Bio and Sail Biomedicines. Strip those one-time items away, and the underlying business looked considerably healthier, with adjusted net earnings landing at $6.3 billion. The real engine behind J&J's growth story continues to be its drug business. Innovative Medicine sales jumped nearly 8% to $16.76 billion, powered by a handful of standout products. Tremfya, the company's immune disease treatment, was the breakout star of the quarter, with sales soaring 68% to $2.4 billion and comfortably beating analyst projections of about $2.19 billion. That growth matters even more given the backdrop. Stelara, once a reliable blockbuster, has been losing ground to generic competition, with sales falling 54% to $716 million. Tremfya has effectively stepped in to fill that gap, aided by recent approvals in inflammatory bowel disease treatment. Elsewhere in the pharmaceutical portfolio, cancer treatment Darzalex grew about 16% to $4.24 billion, and oncology as a whole led the division with 16.7% operational growth, lifted by newer therapies like Carvykti, Tecvayli, and the recently launched Rybrevant and Lazcluze combination. Medtech told a far less flattering story. Sales rose just 2.5% to $8.6 billion, missing analyst estimates and drawing a notably blunt assessment from Chief Financial Officer Joe Wolk. "Medtech needs to improve quite frankly," Wolk told Bloomberg , acknowledging that the segment underperformed internal expectations. He pointed to a mix of external pressures weighing on the business, including geopolitical tension in the Middle East, budget tightening among European governments, and ongoing pricing pressure in China. In an interview with Reuters , Wolk elaborated on the Middle East dynamic specifically, noting that countries like Kuwait, the UAE, and Saudi Arabia still want premium healthcare systems, "but their budgets now are being resourced and allocated towards defense." Within medtech, cardiovascular products were the bright spot, growing 4.1% on the strength of new electrophysiology platforms, while surgery sales actually declined slightly, hurt by procurement changes in China and the same regional disruptions in the Middle East. One genuine bright spot inside medtech came from the FDA's decision to authorize the company's Ottava robotic surgical system , which J&J is positioning as a legitimate new category in surgical robotics rather than just another entrant into an increasingly crowded field. The system is built around four robotic arms integrated directly into a standard surgical table rather than mounted on separate carts or booms, a design the company says takes up 30% to 50% less operating room space than competing systems. Its initial clearance covers ten general surgery procedures, including gastric bypass and hernia repair, and the company says it has already signed its first commercial customer. Perhaps the biggest strategic headline of the quarter had nothing to do with the current numbers at all. J&J confirmed it intends to spin off its orthopedics business, DePuy Synthes , into a standalone company, with CFO Wolk telling CNBC the company is now targeting mid-2027 for the separation. He made clear the company isn't rushing into a sale just because one is on the table. "We're not cash strapped. We don't have to pursue a deal that maybe is not optimal," Wolk said, adding that J&J has the flexibility to "sit this out for a little bit" before executing the separation on its own timeline. That comment comes against the backdrop of reports that Apollo Global Management has been in talks to acquire the orthopedics unit in a deal that could value it near $20 billion, though Wolk's remarks to Bloomberg suggested the company is leaning toward a straightforward spinoff rather than an outright sale, calling it "the greatest way to create value." Looking at the bigger picture, CEO Joaquin Duato framed the quarter as confirmation that the company's long-term strategy is working, pointing to the Ottava authorization alongside "positive Phase 3 results in multiple myeloma" as proof points. In a separate statement, he said the quarter's performance gives the company "clearer line of sight to double-digit growth by the end of the decade," a target executives say is being driven by internal pipeline execution rather than any assumed wave of acquisitions, even as the company says it remains open to opportunities if they arise. For now, J&J finished the quarter with $17 billion in cash and marketable securities against $45 billion in debt, generated roughly $15 billion in free cash flow over the first nine months of the year, and returned $3.2 billion to shareholders through dividends, continuing a streak that now stretches 55 consecutive years of annual increases. Investors, however, appeared less interested in that stability than in the open questions still hanging over the company. Management has promised more detail on both 2027 guidance and the orthopedics separation at an investor event scheduled for December 8, 2026, leaving the market to wait for clarity on whether medtech can turn itself around and whether the DePuy Synthes exit will unfold on the company's preferred terms.

AcquisitionPhase 3

13 Oct 2026

·www.biospace.com

Johnson & Johnson reports Q3 2026 results, raises 2026 guidance

2026 Third-Quarter reported sales growth of 5.9% to $25.4 Billion with operational growth of 6.0%* and adjusted operational growth of 6.1%* 2026 Third-Quarter earnings per share (EPS) of $0.09 reflects a one-time special charge for the proposed talc litigation resolution, the acquisition of Firefly Bio, Inc., and the strategic collaboration with Sail Biomedicines; adjusted EPS* of $2.59 also reflects the impact of these M&A deals Strong operational performance results in the Company increasing 2026 guidance with estimated reported sales of $101.2 Billion or 7.4% at the midpoint and increasing adjusted EPS* guidance by $0.06 to $11.10 or 2.9% at the midpoint Significant innovation including the market authorization of OTTAVA as the world’s first table-integrated soft tissue robotic system, approval of IMAAVY in warm autoimmune hemolytic anemia (wAIHA), and priority review for RYBREVANT FASPRO for advanced head and neck cancer NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2026. “Johnson & Johnson’s strong third-quarter performance and increased sequential growth reflect the accelerating momentum of our focused portfolio,” said Joaquin Duato, Chairman and Chief Executive Officer. “In the third quarter, we advanced breakthroughs that will redefine care for patients, from delivering one of our most transformative MedTech innovations with OTTAVA to reporting positive Phase 3 results in multiple myeloma. This progress, together with strategic investments in high-growth areas, gives us clearer line of sight to double-digit growth by the end of the decade.” Overall financial results Q3 ($ in Millions, except EPS) 2026 2025 % Change Reported Sales $25,399 $23,993 5.9% Net Earnings $210 $5,152 (95.9)% EPS (diluted) $0.09 $2.12 (95.8)% Q3 Non-GAAP* ($ in Millions, except EPS) 2026 2025 % Change Operational Sales 1,2 6.0% Adjusted Operational Sales 1,3 6.1% Adjusted Net Earnings 1,4 $6,339 $6,801 (6.8)% Adjusted EPS (diluted) 1,4 $2.59 $2.80 (7.5)% Free Cash Flow 5,6 ~$15,100 $14,226 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Non-GAAP financial measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 6 Third-quarter YTD 2026 is estimated as of October 13, 2026 Note: values may have been rounded Regional sales results Q3 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 U.S. $14,959 $13,708 9.1% 9.1 - 9.1 International 10,440 10,285 1.5 1.8 (0.3) 1.9 Worldwide $25,399 $23,993 5.9% 6.0 (0.1) 6.1 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q3 % Change ($ in Millions) 2026 2025 Reported Operational 1,2 Currency Adjusted Operational 1,3 Innovative Medicine $16,757 $15,563 7.7% 7.9 (0.2) 8.0 MedTech 8,642 8,430 2.5 2.5 0.0 2.5 Worldwide $25,399 $23,993 5.9% 6.0 (0.1) 6.1 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Third-Quarter 2026 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 7.9%*, with divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by TREMFYA and new products within Other in Immunology, DARZALEX, CARVYKTI, TECVAYLI, RYBREVANT/LAZCLUZE, and ERLEADA in Oncology, and SPRAVATO and CAPLYTA in Neuroscience. Growth was partially offset by STELARA (an approximate 690 basis points impact), SIMPONI/SIMPONI ARIA, and REMICADE in Immunology, as well as OPSUMIT/OPSYNVI in Pulmonary Hypertension, and IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 2.5%*. Growth was primarily driven by electrophysiology products and Shockwave in Cardiovascular, contact lenses in Vision, as well as trauma in Orthopaedics. Full-year 2026 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2026 July 29, 2026 Adjusted Operational Sales 1,2 Change vs. Prior Year / Mid-point 6.4% – 6.8% / 6.6% 6.2% – 6.8% / 6.5% Operational Sales 2 / Mid-point Change vs. Prior Year / Mid-point $100.5B – $100.9B /$100.7B 6.7% – 7.1% / 6.9% $100.3B – $100.9B / $100.6B 6.5% – 7.1% / 6.8% Estimated Reported Sales 3 / Mid-point Change vs. Prior Year / Mid-point $101.0B – $101.4B / $101.2B 7.2% – 7.6% / 7.4% $100.8B – $101.4B / $101.1B 7.0% – 7.6% / 7.3% Adjusted Operational EPS (Diluted) 2,4 / Mid-point Change vs. Prior Year / Mid-point $10.95 – $11.05 / $11.00 1.5% – 2.4% / 2.0% $10.86 – $11.01 / $10.94 0.7% – 2.1% / 1.4% Adjusted EPS (Diluted) 3,4 / Mid-point Change vs. Prior Year / Mid-point $11.05 – $11.15 / $11.10 2.4% – 3.3% / 2.9% $10.96 – $11.11 / $11.04 1.6% – 3.0% / 2.3% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: October 2026 = $1.15 and July 2026 = $1.15 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items Note: percentages may have been rounded Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at , or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News , as well as Innovative Medicine Newsroom , MedTech News & Events , and . Regulatory Johnson & Johnson Receives CE Marking for ACUVUE OASYS MAX Reusable Contact Lenses 1 Press Release FDA approves IMAAVY ® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients Press Release Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer Press Release Johnson & Johnson Receives FDA Market Authorization in the U.S. for its OTTAVA™ Robotic Surgical System Press Release Johnson & Johnson Announces MONARCH™ QUEST 3, Advancing the Latest in Robotically-Assisted Bronchoscopy Press Release Data Releases New Johnson & Johnson ICOTYDE ® (icotrokinra) long-term data demonstrate robust 2- year results in the treatment of adults and adolescents with plaque psoriasis 1 Press Release Johnson & Johnson announces new ICOTYDE™ (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy 1 Press Release Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY ® (nipocalimab-aahu) in generalized myasthenia gravis (gMG) Press Release Johnson & Johnson announces TREMFYA ® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study Press Release Single infusion of CARVYKTI ® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma Press Release New model-based analysis further supports the potential of TECVAYLI ® (teclistamab-cqyv) plus DARZALEX FASPRO ® (daratumumab and hyaluronidase-hj) to redene long-term survival expectations in early line relapsed/refractory multiple myeloma Press Release CAPLYTA ® (lumateperone) shows significant and rapid improvement in bipolar mania in pivotal Phase 3 study Press Release RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE ® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 Press Release Johnson & Johnson's RYBREVANT ® (amivantamab-vmjw) plus chemotherapy delivers longest reported median overall survival in EGFR exon 20 insertion mutation-positive lung cancer Press Release Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026 Press Release TECVAYLI ® + TALVEY ® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma Press Release Other New Global Survey by Johnson & Johnson Finds Most Women Don’t Connect Eye Health Changes with Menopause 1 Press Release Johnson & Johnson’s Executive Vice President Jennifer Taubert to Retire; Tom Cavanaugh Appointed EVP, Worldwide Chairman Innovative Medicine Effective September Press Release Johnson & Johnson Completes Acquisition of Firefly Bio, Inc. to Advance Next-Generation Oncology Innovation Press Release Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune Reset Press Release Johnson & Johnson Announces a Proposed Resolution of Ovarian Talc Litigation Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations . About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results . Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results . These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results . Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the Company's ability to successfully separate the Company's Orthopaedics business and realize the anticipated benefits from the planned separation. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , investor.jnj.com , or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) THIRD QUARTER NINE MONTHS Percent Change Percent Change 2026 2025 Total Operations Currency 2026 2025 Total Operations Currency Sales to customers by segment of business Innovative Medicine U.S. $ 10,447 9,402 11.1 % 11.1 - $ 29,297 26,655 9.9 % 9.9 - International 6,310 6,161 2.4 3.0 (0.6 ) 19,270 17,983 7.2 3.6 3.6 16,757 15,563 7.7 7.9 (0.2 ) 48,567 44,638 8.8 7.4 1.4 MedTech U.S. 4,512 4,306 4.8 4.8 - 13,525 12,902 4.8 4.8 - International 4,130 4,124 0.1 0.1 0.0 12,679 12,089 4.9 2.2 2.7 8,642 8,430 2.5 2.5 0.0 26,204 24,991 4.9 3.5 1.4 U.S. 14,959 13,708 9.1 9.1 - 42,822 39,557 8.3 8.3 - International 10,440 10,285 1.5 1.8 (0.3 ) 31,949 30,072 6.2 3.0 3.2 Worldwide $ 25,399 23,993 5.9 % 6.0 (0.1 ) $ 74,771 69,629 7.4 % 6.0 1.4 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) THIRD QUARTER NINE MONTHS Percent Change Percent Change 2026 2025 Total Operational Currency 2026 2025 Total Operational Currency Sales to customers by geographic area U.S. $ 14,959 13,708 9.1 % 9.1 - $ 42,822 39,557 8.3 % 8.3 - Europe 5,405 5,440 (0.6 ) 1.0 (1.6 ) 16,979 15,937 6.5 2.3 4.2 Western Hemisphere excluding U.S. 1,385 1,231 12.5 8.0 4.5 3,987 3,604 10.6 4.5 6.1 Asia-Pacific, Africa 3,650 3,614 1.0 1.0 0.0 10,983 10,531 4.3 3.6 0.7 International 10,440 10,285 1.5 1.8 (0.3 ) 31,949 30,072 6.2 3.0 3.2 Worldwide $ 25,399 23,993 5.9 % 6.0 (0.1 ) $ 74,771 69,629 7.4 % 6.0 1.4 Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) THIRD QUARTER 2026 2025 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) Sales to customers $ 25,399 100.0 $ 23,993 100.0 5.9 Cost of products sold 8,097 31.9 7,303 30.4 10.9 Gross Profit 17,302 68.1 16,690 69.6 3.7 Selling, marketing and administrative expenses 6,285 24.7 5,922 24.7 6.1 Research and development expense 4,652 18.3 3,672 15.3 26.7 In-process research and development impairments 339 1.4 - - Interest (income) expense, net 31 0.1 18 0.1 Other (income) expense, net 5,780 22.8 (478 ) (2.0 ) Restructuring 181 0.7 63 0.3 Earnings before provision for taxes on income 34 0.1 7,493 31.2 (99.5 ) (Benefit from)/Provision for taxes on income (176 ) (0.7 ) 2,341 9.7 (107.5 ) Net earnings $ 210 0.8 $ 5,152 21.5 (95.9 ) Net earnings per share (Diluted) $ 0.09 $ 2.12 (95.8 ) Average shares outstanding (Diluted) 2,448.6 2,428.6 Effective tax rate (517.6 ) % 31.2 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 7,672 30.2 $ 8,436 35.2 (9.1 ) Net earnings $ 6,339 25.0 $ 6,801 28.3 (6.8 ) Net earnings per share (Diluted) $ 2.59 $ 2.80 (7.5 ) Effective tax rate 17.4 % 19.4 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) NINE MONTHS 2026 2025 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) Sales to customers $ 74,771 100.0 $ 69,629 100.0 7.4 Cost of products sold 24,254 32.4 22,288 32.0 8.8 Gross Profit 50,517 67.6 47,341 68.0 6.7 Selling, marketing and administrative expenses 18,751 25.1 16,923 24.3 10.8 Research and development expense 11,832 15.8 10,413 15.0 13.6 In-process research and development impairments 375 0.5 - - Interest (income) expense, net 136 0.2 (62 ) (0.1 ) Other (income) expense, net 6,405 8.6 (7,692 ) (11.1 ) Restructuring 247 0.3 144 0.2 Earnings before provision for taxes on income 12,771 17.1 27,615 39.7 (53.8 ) Provision for taxes on income 1,792 2.4 5,927 8.6 (69.8 ) Net earnings $ 10,979 14.7 $ 21,688 31.1 (49.4 ) Net earnings per share (Diluted) $ 4.49 $ 8.94 (49.8 ) Average shares outstanding (Diluted) 2,445.8 2,424.8 Effective tax rate 14.0 % 21.5 % Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 24,153 32.3 $ 24,635 35.4 (2.0 ) Net earnings $ 20,034 26.8 $ 20,206 29.0 (0.9 ) Net earnings per share (Diluted) $ 8.19 $ 8.33 (1.7 ) Effective tax rate 17.1 % 18.0 % (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures Third Quarter Nine Months Ended (Dollars in Millions Except Per Share Data) 2026 2025 2026 2025 Net Earnings, after tax- as reported $210 $5,152 $10,979 $21,688 Pre-tax Adjustments Litigation related 5,519 15 6,116 (6,894 ) Intangible Asset Amortization expense 1,240 1,048 3,732 3,435 Restructuring related 1 195 168 533 302 Orthopaedics separation related 369 - 746 - Acquisition, integration and divestiture related (34 ) 97 142 475 (Gains)/losses on securities 10 (387 ) (262 ) (327 ) IPR&D impairments 339 - 375 - Other - 2 - 29 Tax Adjustments Tax impact on special item adjustments 2 (1,677 ) (168 ) (2,469 ) 826 Tax legislation and other tax related 168 874 142 672 Adjusted Net Earnings , after tax $6,339 $6,801 $20,034 $20,206 Average shares outstanding (Diluted) 2,448.6 2,428.6 2,445.8 2,424.8 Adjusted net earnings per share (Diluted) $2.59 $2.80 $8.19 $8.33 Operational adjusted net earnings per share (Diluted) $2.61 $8.04 Notes: 1 In the fiscal second quarter of 2026, the Company initiated a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially completed by the end of fiscal year 2029 with estimated costs between $650 - $750 million, and include site and supplier exit costs, decommissioning and asset impairment costs. Restructuring expenses of $74 million in the fiscal third quarter of 2026 ($274 million Q3 2026 YTD), were primarily related to asset impairments and exit costs. In fiscal 2025, the Company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. Restructuring expenses of $80 million were recorded in the fiscal third quarter of 2026 ($194 million Q3 2026 YTD) and $128 million in the fiscal third quarter of 2025 ($157 million Q3 2025 YTD) primarily includes costs related to product exits. This program is expected to be substantially completed by the end of fiscal year 2026. In fiscal 2023, the Company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expenses of $41 million in the fiscal third quarter of 2026 ($65 million Q3 2026 YTD) and $40 million in the fiscal third quarter of 2025 ($145 million Q3 2025 YTD) includes costs related to market and product exits. This program will be completed as of Q4 2026 at a total cost of approximately $1 billion. 2 The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings. Contacts Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com Read full story here

Phase 3Executive ChangeDrug ApprovalFinancial StatementClinical Result

17 Sep 2026

·www.biospace.com

Altis Labs AI Imaging Endpoint Predicts Overall Survival Benefit in Phase 3 Lung Cancer Trial: Data Presented at IASLC WCLC 2026

IPRO Response Rate detected treatment effects missed by ORR, eleven months before primary PFS readout and 26 months before final OS readout in a post hoc analysis. TORONTO--(BUSINESS WIRE)--Altis Labs, Inc. (“Altis”), the AI endpoint company accelerating clinical trials, today announced findings from an independent post-hoc analysis evaluating its AI-powered imaging endpoint, IPRO, in the MARIPOSA Phase 3 trial. 1 The findings, which were presented at the World Conference on Lung Cancer (WCLC) 2026 in Seoul, Republic of Korea, show that Altis’ IPRO Response Rate detected an early, notable treatment effect, while RECIST-based objective response rate (ORR) failed to anticipate the investigational treatment’s 12+ month median overall survival (OS) benefit. IPRO Response Rate provides early efficacy signal in EGFR-mutated NSCLC In a post-hoc analysis performed by the trial sponsor, IPRO demonstrated its value as an early endpoint in the trial, which compared treatments in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). The IPRO AI model automatically analyzed approximately 10,000 radiology scans, generating prognostic outcome measures for each patient at baseline and on-treatment assessments. IPRO Response was defined as a ≥50% improvement in the IPRO-α score relative to baseline, and the treatment effect was estimated as the IPRO Response Rate ratio for the investigational treatment versus control arm treatment at landmark early imaging assessments. Key findings include: IPRO Response Rate favored the investigational treatment beginning at Week 16 (IPRO Response Rate Ratio, 1.33; 95% CI, 1.03-1.71) and throughout subsequent time points, while ORR failed to anticipate the significant OS benefit throughout. When evaluating pooled, patient-level IPRO trajectories over time, IPRO deterioration was consistently associated with OS detriment, while IPRO improvement was consistently associated with OS benefit. IPRO scores for the entire trial were generated automatically from routinely acquired CT imaging, providing an objective, reproducible measure of efficacy. “This readout proves that AI can anticipate meaningful clinical benefit that traditional imaging endpoints like ORR may fail to detect,” said Felix Baldauf-Lenschen, Founder and CEO of Altis Labs. “We’re focused on supporting our biopharma partners and ultimately patients by bringing this level of precision into clinical trials so that efficacy can be detected earlier.” The results were presented on September 13th, 2026, at WCLC, Abstract/Poster: P1.046: IPRO-a Response Rate as a Potential Early Endpoint for Overall Survival in MARIPOSA, a Phase 3 Trial in EGFR-Mutated NSCLC. Abstract can be viewed at: About IPRO IPRO is a fully automated AI system that predicts patient survival directly from the CT scans already acquired in clinical trials. Rather than automating RECIST, IPRO goes beyond measuring target lesion size by analyzing the entire three-dimensional scan to quantify thousands of prognostic imaging biomarkers spanning tumor burden, body composition, and organ health that contribute to multifactorial survival outcomes. At the patient-level, improvements in IPRO (i.e. IPRO Response) are associated with survival benefit, while IPRO deterioration is associated with survival detriment. Clinical trial sponsors use IPRO Response Rate as a novel, survival-linked endpoint to detect early efficacy signals and navigate go/no-go decisions with greater confidence. About Non-Small Cell Lung Cancer (NSCLC) NSCLC accounts for up to 85% of all lung cancer cases worldwide and is the leading cause of cancer death. Epidermal growth factor receptor (EGFR) alterations represent one of the most common driver mutations, found in 10% to 15% of Western patients and up to 40% to 50% of Asian patients with adenocarcinoma histology. Despite advances in targeted therapies, the five-year survival rate for patients with advanced EGFR-mutated NSCLC treated with standard-of-care remains under 20%. About Altis Labs Altis Labs is the AI endpoint company accelerating clinical trials. Altis was founded on the premise that AI's greatest potential lies in generating better evidence, faster. In close partnership with leading cancer centers, Altis has trained a prognostic AI model, IPRO, on the industry’s largest multimodal oncology database comprising longitudinal imaging, molecular, clinical, and outcomes data spanning over 500,000 patient years. Top 20 biopharma companies use IPRO to more confidently analyze data from phase 1-4 clinical trials so that they can bring the most effective novel treatments to patients sooner. For more information, visit , follow @AltisLabs on social media, or email info@altislabs.com . ____________________ 1 Cho BC, Lu S, Felip E, et al. Amivantamab plus Lazertinib in Previously Untreated EGFR -Mutated Advanced NSCLC. N Engl J Med. 2024;391(7):585-598. doi:10.1056/NEJMoa2403614 Contacts Altis Labs, Inc. info@altislabs.com Colin Sanford colin@bioscribe.com

100 Deals associated with Lazertinib Mesylate

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KEGG	Wiki	ATC	Drug Bank
D11980	-	-	DB16216

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	Japan	Janssen Pharmaceutical KK	27 Mar 2025
EGFR positive non-small cell lung cancer	United Kingdom	Janssen-Cilag Ltd.	06 Mar 2025
Non-Small Cell Lung Cancer	Canada	Janssen, Inc.	06 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	South Korea	Yuhan Corp.	18 Jan 2021
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	South Korea	Yuhan Corp.	18 Jan 2021
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	South Korea	Yuhan Corp.	18 Jan 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Argentina	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Israel	Janssen Research & Development LLC	05 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05601973 (AMAZE-lung, Pubmed \| Lancet Respir Med)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR-mutant	61	LazertinibAmivantamab + LazertinibAmivantamab + LazertinibAmivantamab	hgrntrqzvu(vnzmzvpaxg) = dtoglvyggt wahninqkcj (ojukgpbevo, 21 - 47) View more	Positive	01 Oct 2026
WCLC2026	Not Applicable	Metastatic Malignant Neoplasm to the Leptomeninges \| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	61	Lazertinib + Pemetrexed/Carboplatin (T790M-negative)	pyqggtznyh(llrbrqyqpx) = blgjtblzgo xtouxqredu (swdedseybk, 6.8 - 18.1) View more	Positive	12 Sep 2026
				Lazertinib + Pemetrexed/Carboplatin (T790M-positive)	pyqggtznyh(llrbrqyqpx) = jgzvokyyis xtouxqredu (swdedseybk, 10.6 - NR) View more
WCLC2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutant	200	Lazertinib	ylmhburrrs(tprwhvialg) = yyldlpausb xsnogrkvfw (gyztfygfbk )	Positive	12 Sep 2026
WCLC2026	Not Applicable	metastatic non-small cell lung cancer Second line EGFR exon 19 deletion \| L858R mutations	185	Osimertinib	btjgruuzsz(cqjmsuevpi) = pwinnsupgm cqdgbjgsnk (wtzcoqgvvh, 6.5 - 25.2) View more	Positive	12 Sep 2026
				Lazertinib	btjgruuzsz(cqjmsuevpi) = ylqtghqlfz cqdgbjgsnk (wtzcoqgvvh, 7.3 - 12.6) View more
WCLC2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutation	123	Osimertinib	nwesgydtia(qfrvlchxts) = qozmszsrok waagcnxdby (aescmpoaja )	Positive	12 Sep 2026
				Lazertinib	nwesgydtia(qfrvlchxts) = wjucbdwdhp waagcnxdby (aescmpoaja )
WCLC2026	Phase 2	Non-Small Cell Lung Cancer First line EGFR mutations	149	Lazertinib 240 mg	bnntheuavn(vvmhagswuz) = rtpvyluidr uizafdrgst (oxshanjaxw, 16.8 - 30.3)	Positive	12 Sep 2026
				Lazertinib 240 mg (Del 19)	bnntheuavn(vvmhagswuz) = smfhmrozoj uizafdrgst (oxshanjaxw, 21.9 - NA)
NCT05299125 (AMIGO-1, WCLC2026)	Phase 2	Non-Small Cell Lung Cancer First line EGFR-mutant	54	Amivantamab+Lazertinib+Pemetrexed	darbuyeihv(kmllrylgmm) = kegidvjlpe kkoslkrdkp (jcvbtxfxbj, 57.5 - 74.4) View more	Positive	12 Sep 2026
WCLC2026	Not Applicable	Non-Small Cell Lung Cancer First line	1,198	Second-generation EGFR-TKIs (afatinib or dacomitinib)	joaoznetmp(kdyprqckri): HR = 1.107 (95.0% CI, 0.86 - 1.426), P-Value = 0.431 View more	Positive	12 Sep 2026
				Third-generation EGFR-TKIs (osimertinib or lazertinib)
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer Second line EGFR-mutant	4,909	Platinum-pemetrexed chemotherapy (Chemo)	yhinxpnwxd(htogvlxzoa): HR = 1.92 View more	Positive	29 May 2026
				immunotherapy +Chemo (IC)
WJOG17323L (ASCO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutations	70	Amivantamab + lazertinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	pdipgfttni(qnarctwvzb) = yyquwqznwc exxtjauvdt (jbiveywxpj ) View more	Positive	29 May 2026
				Afatinib (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve)	pdipgfttni(qnarctwvzb) = zztcwoxnml exxtjauvdt (jbiveywxpj ) View more

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