Amivantamab-VMJM

The primary endpoint of Cullinan Therapeutics\' phase 2b portion a trial of its lead asset was the overall response rate at 24 months.\n Cullinan Therapeutics has announced that its lead asset has aced a midstage lung cancer trial—but the biotech is keeping the data close to its chest for now.The drug in question, zipalertinib, is an EGFR ex20ins inhibitor that the Cambridge, Massachusetts-based biotech has been investigating in a phase 2b trial in collaboration with Japan’s Taiho Pharmaceutical. The study enrolled patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have received prior therapy.The primary endpoint of the phase 2b portion of the trial was the overall response rate at 24 months, and the biotechs announced in a post-market release Jan. 28 that the study has hit this endpoint.“The safety profile was generally consistent with previous data presentations,” added the companies, who are withholding all data from the trial for “an upcoming international medical conference.” Still, Cullinan and Taiho clearly liked what they saw—their plan now is to submit an approval application to the FDA in the second half of this year.The signs were promising as far back as September 2024, when Cullinan presented data at the European Society for Medical Oncology Congress from patients with EGFR ex20ins NSCLC who have progressed on or after prior amivantamab treatment. The presentation showed a “consistent objective response rate of approximately 40% and a manageable safety profile,” the company explained.Cullinan rebranded from Cullinan Oncology last year as the biotech became the latest CD19-focused cancer company to dip its toe into the autoimmune space. The biotech used the same April 2024 announcement to disclose it had brought in $280 million via a private placement of its shares, which it estimated would stretch out its cash runway through to 2028.

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.”