TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial
U.S. FDA approves AstraZeneca`s Tagrisso-chemo combo
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AstraZeneca is tossing a little cash towards Allorion Therapeutics to pick up a friend for approved lung cancer med Tagrisso.
WILMINGTON, Del.--(BUSINESS WIRE)--Results from a prespecified exploratory analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy demonstrated a 42% improvement in central nervous system (CNS) progression-free survival (PFS), compared to TAGRISSO alone for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) and brain metastases at baseline, representing 40% of patients in the trial, as assessed by blinded independent central review (BICR).
A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.
AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Johnson & Johnson said that its combination treatment staved off cancer progression for longer than AstraZeneca’s blockbuster Tagrisso as a first option for patients with a form of advanced lung cancer.
TAGRISSO® (osimertinib) Plus Chemotherapy Extended Median Progression-free Survival by Nearly 9 Months in EGFR-mutated Advanced Lung Cancer in FLAURA2 Phase III Trial
RARITAN, N.J., Sept. 6, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the three-arm Phase 3 MARIPOSA-2 study evaluating RYBREVANT® (amivantamab-vmjw), a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), given with and without lazertinib, an oral, third-generation EGFR tyrosine kinase inhibitor (TKI), combined with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone. MARIPOSA-2 enrolled patients with locally advanced or metastatic EGFR exon 19 deletions (ex19del) or L858R substitution NSCLC after disease progression on or after osimertinib. The study met its dual primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS versus chemotherapy alone in both experimental treatment arms. No new safety signals were found for the addition of RYBREVANT® to chemotherapy.1 Janssen plans to submit these results for presentation at upcoming scientific congresses, including details on secondary endpoints such as overall survival (OS), objective response, duration of response (DoR) and intracranial PFS.