EU approves Roche’s Columvi (glofitamab) CMA for r/r DLBCL; Orphan Maintained

• Approval based on a pivotal cohort in the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting responses in people with R/R DLBCL

• Results showed that Columvi given as a fixed course, induced a complete response in 35.2% (n =38/108) of people, and 50% (n=54/108) achieved an overall response; among those who achieved a CR, 74.6% (95% CI: 59.19-89.93) continued to experience a response at 12 months, while the median duration of CR was not reached.

• FDA granted accelerated approval for a similar indication in June. In both the US and Europe, Study GO41944 is designed to confirm benefit with a primary endpoint of OS

FDA converts BLINCYTO (blinatumomab) to full approval for the treatment of adults and pediatric patients with MRD-positive ALL

• Approval converts the 2018 accelerated approval, which was based on the single-arm BLAST trial (NCT 01207388) that included 86 patients

• Follows completion of PMR 3366-2, to complete a randomized trial to verify clinical benefit of blinatumomab in pediatric patients in morphologic complete remission with detectable minimal residual disease

• Amgen formally released from second PMR (3366-1) as the original accelerated approval provided two routes to confirm benefit (met by the fulfilment of PMR 3366-2)

FDA Grant Accelerated Approval for Genentech’s Bispecific Antibody, Columvi in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Accelerated approval based Phase I/II NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with r/r DLBCL, including about 30% who had received prior CAR T-cell therapy; 83% were refractory to their most recent therapy

• Results showed 56% of patients achieving an overall response, 43% achieving a complete response

• Over two-thirds of those who responded continued to respond for at least nine months (68.5%)

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer

• FDA follows ODAC advice, approving the sNDA for the restricted indication of BRCA-mutated mCRPC

• Exploratory subgroup analysis in 85 patients with BRCAm (11% of ITT population) demonstrated a median rPFS that was not reached in the olaparib with abiraterone arm compared to 8 months (95% CI: 6, 15) for those receiving placebo with abiraterone (HR 0.24)

• OS HR in these patients was 0.30 (95% CI: 0.15, 0.59)

FDA Approves AYVAKIT (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis

• Efficacy was based on the absolute mean change from baseline to Week 24 in the Indolent Systemic Mastocytosis-Symptom Assessment Form (ISM-SAF) total symptom score (TSS)

• AYVAKIT demonstrated significant improvements versus PBO in the primary and all key secondary endpoints, including overall symptoms and measures of mast cell burden

• AYVAKIT was well-tolerated with a favorable safety profile compared to placebo, and most adverse reactions were mild to moderate in severity

FDA Approve EPKINLY™ (epcoritamab-bysp) as the First Bispecific Antibody to Treat Adults with r/r DLBCL

• EPKINLY monotherapy demonstrated responses in DLBCL patients who have received at least two prior treatments

• Overall response (complete or partial response) was seen in 61% (90/148) of patients and 38% (56/148) achieved complete remission

• Median DOR was 15.6 months (95 percent CI: 9.7-Not reached)

Servier receives EU approval of Tibsovo® in IDH1-mutated AML and IDH1-mutated Cholangiocarcinoma

• In AML, a statistically significant improvement in EFS HR 0.33; & OS HR 0.44 was seen in patients treated with Tibsovo® in combination with AZA vs. AZA + PBO

• In cholangiocarcinoma, a statistically significant improvement in PFS HR 0.37 was observed; mPFS for Tibsovo® and placebo was 2.7 and 1.4 months, respectively

European Commission Approves BMS CAR T Breyanzi r/r Large B-cell Lymphoma After One Prior Therapy

• Breyanzi more than quadrupled median EFS compared to standard therapy (10.1 months vs. 2.3 months [HR: 0.349; 95% CI (0.229-0.530) p<0.0001]) at an interim analysis with a median follow-up of 6.2 months

• Results of the primary analysis, with a median follow-up of 17.5 months were consistent with the interim analysis, with median EFS not reached for Breyanzi (95% CI: 9.5-NR) vs. 2.4 months for standard therapy (95% CI: 2.2-4.9)