Summit Therapeutics announces initial indications for clinical trials for SMT112

Summit Therapeutics announced that it has determined its first two indications in non-small cell lung cancer NSCLC in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab. Summit has held multiple meetings with the US Food and Drug Administration during the first quarter of 2023 regarding its planned Phase III clinical program and incorporated this feedback accordingly. We plan to initiate clinical studies in the following indications: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor EGFR -mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor …"I am immensely proud of the speed and efficiency of our team to enable clinical trials for SMT112," stated Robert W. Duggan, Chairman & Chief Executive Officer of Summit. "I am particularly enthusiastic about the potential of ivonescimab: this shared enthusiasm is the impetus behind Team Summit’s rapid development to enter into multiple Phase III clinical trials with SMT112. With our confidence in our ability to clinically develop, achieve regulatory approvals, and effectively commercialize a quality product, we believe that we have the opportunity to make a significant difference in the lives of those patients who could benefit from this innovative therapy." "Our agreement to in-license ivonescimab from our high-achieving partner, Akeso, went effective this past January," added Dr. Maky Zanganeh, Co-CEO & President of Summit. "In just over three months’ time, we are preparing to enroll patients in our first Phase III clinical trial, while actively preparing to launch our second Phase III study later this year. The commitment, preparation, diligence, and vision of Team Summit is shining brightly today and reflects the work we have completed to maximize the opportunities for the success of ivonescimab." Ivonescimab is an investigational product and is not approved for use by any health authority. Its efficacy and safety for the treatment of any indication have not been established.