Osimertinib mesylate

Both Tagrisso and Imfinzi have been recommended by England’s NICE to treat patients with lung cancer in England and Wales. Credit: Roland Magnusson via Getty Images. AstraZeneca has received two separate recommendations from England’s National Institute for Health and Care Excellence (NICE) for the use of its lung cancer treatments, Tagrisso (osimertinib) and Imfinzi (durvalumab), within England and Wales’s National Health Service (NHS). Tagrisso has been recommended as an adjuvant therapy following complete surgical resection in adults with stage 1B to 3A non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor (EGFR) exon 19 deletions or exon 21 substitution mutations. The NICE decision was supported by data from the Phase III ADAURA trial (NCT05120349), which demonstrated that post-surgical treatment with Tagrisso reduced the relative risk of disease recurrence or death by 83% compared to placebo in patients with stage 2 to 3A EGFR-mutated NSCLC. At two years, 90% of patients receiving Tagrisso were disease-free, compared to 44% in the placebo group. Among patients with stage 1B to 3A disease, 89% administered with AstraZeneca’s treatment were alive and disease-free at 24 months compared to 52% in the placebo group. Meanwhile, Imfinzi has been recommended in combination with the chemotherapy etoposide and either carboplatin or cisplatin for the treatment of adults with untreated extensive-stage small cell lung cancer (SCLC). NICE’s decision was based on results from the Phase III CASPIAN trial (NCT03043872), which demonstrated that adding Imfinzi to standard chemotherapy provided a significant and sustained overall survival (OS) benefit. At three years, the Imfinzi combination reduced the risk of death by 29% compared to chemotherapy alone. Lung cancer remains the most common cause of cancer-related deaths in the UK, and accounts for nearly 50,000 new cases annually, according to Cancer Research UK. A 2023 report from Frontier Economics estimated that lung cancer costs the UK economy £699m each year. While AstraZeneca has established itself as a key player in lung cancer treatment, Tagrisso faces competition. Johnson & Johnson (J&J) announced updated results from its Phase III MARIPOSA trial (NCT04487080) earlier this month, which tested the combination of its lung cancer drugs Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). J&J claims the combination demonstrated a statistically significant OS improvement over Tagrisso by more than one year, though detailed data has not yet been disclosed. Despite the pressure from J&J, AstraZeneca anticipates strong commercial performance from its therapies. Tagrisso and Imfinzi are projected to generate global sales of $8bn and $7bn, respectively, by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. AstraZeneca UK president Tom Keith-Roach said: “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we’ve had 28 positive recommendations by NICE and the Scottish Medicines Consortium since 2021 across multiple cancer types and stages.”

LOS ANGELES--( BUSINESS WIRE )-- Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, provides an overview of key 2024 milestones and outlook into 2025 in a Letter to Shareholders: Dear Kairos Pharma Shareholders, The management team and Board of Directors of Kairos Pharma Ltd. are pleased to provide you with a brief update on the state of business and noteworthy milestones of 2024 and outlook into 2025. Last year was focused on building the foundation for our business based on breakthrough science and impactful therapeutics, while creating the fundamental infrastructure that facilitated our entry into the public markets. Highlights from 2024 include: Closing of our Initial Public Offering and listing of our common stock on the NYSE American stock exchange on September 16, 2024. Agreement with PreCheck Health Services to further develop a biomarker panel to identify patients responsive to ENV105 to target cancer drug resistance in prostate and lung cancer patients. Addition of City of Hope Cancer Center to the Company’s Phase 2 clinical trial of ENV 105 for castrate-resistant prostate cancer. First patient dosed in combination therapy of ENV105 and Osimertinib to improve therapy sensitivity for EGFR-driven lung cancer. Participation in and presentation at various investor conferences and non-deal road shows Initiation of research coverage by two leaders in the healthcare industry, Jason Kolbert of EF Hutton and Tony Butler at Rodman and Renshaw; we look forward to attracting additional research coverage of our exciting clinical programs as we move forward. In 2025, we completed a PIPE transaction, raising gross proceeds of $3.5 million, ensuring continuous execution of our clinical trials and rigorous development of our key preclinical assets. Expansion of patent coverage of our assets to protect our technologies domestically and internationally. Having built the key foundations of our business, we anticipate the following key upcoming milestones for 2025, including: Continuing to execute Phase 2 randomized clinical trial of ENV 105 in prostate cancer. Continue to conduct our Phase 1 clinical trial of ENV 105 in non-small cell lung cancer. Report safety data of both trials and interim efficacy data, with an initial readout of the prostate cancer safety data anticipated in the first half of 2025 and the NSCLC by year end. Presenting data at national scientific meetings. Pre-IND studies of KROS 101, which we also anticipate publishing. Initiation of partnering discussions. In the meantime, we continue to feel confident in the paradigm-shifting potential of our therapeutics, which are based on breakthrough science of our officers. We believe these therapeutics will show the potential to make a lasting impact by stopping the relentless spread of human neoplastic disorders. We continue to be grateful to our partners and our shareholders and look forward to expanding upon our science, while providing value to our shareholders both in the near and long term. We look forward to continuing to provide updates on our progress. Sincerely, John Yu, M.D. CEO Kairos Pharma About Kairos Pharma Ltd. Based in Los Angeles, California, Kairos Pharma Ltd. ( NYSE American: KAPA ) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105—a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com . Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 1 and Phase 2 clinical trials; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s prospectus and other filings made with the SEC. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.