MULTIPLE MYELOMA

Data from the Phase 3 CARTITUDE-4 trial  of ciltacabtagene autoleucel (Carvykti), aBCMA-targeting CAR T-cell therapy, show that patients in the Carvykti arm had asignificantly improved objective response rate (85% vs. 67%), and rate of completeresponse (73% vs. 22%) compared to standard-of-care regimens.

HODGKIN'S LYMPHOMA (HL)

Data presented at ASCO showed that Opdivo reducedthe risk of disease-related death by 52% as comparedwith Adcetris at a median follow-up of 12.1 months inadvanced patients. Patients treated with Opdivo had a94% progression-free survival rate after one year, asopposed to 86% in the Adcetris arm. Furthermore,Opdivo exhibited better safety results with fewer deathsattributed to adverse events.

NON-SMALL CELL LUNG CANCER (NSCLC)

Pfizer announced initial results from the Phase 2PHAROS study, evaluating the combination ofBRAFTOVI (encorafenib) and MEKTOVI (binimetinib) inpatients with BRAF V600E-mutant metastatic NSCLC.The study showed a 75% objective response rate (ORR)in treatment-naïve patients and a 46% ORR inpreviously treated patients. The combination therapyalso demonstrated a manageable safety profile. TheFDA is currently reviewing Pfizer’s Supplemental NewDrug Applications (sNDAs), which are supported by thePhase 2 PHAROS trial.

HER2-EXPRESSING ADVANC ED SOLID TUMORS

Enhertu, a HER2-directed antibody-drug conjugate (ADC),demonstrated a 37.1% objective response rate (ORR) in atrial involving patients with advanced solid tumorsexpressing HER2. The trial focused on third-line treatmentfor various cancers, including biliary tract, bladder,cervical, endometrial, ovarian, and pancreatic cancers.Patients with the highest HER2 expression levels achieveda confirmed ORR of 61.3% through central testing. Amongthe participants, 15 showed a complete response, while 84experienced partial responses. Furthermore, nearly half ofthe patients who responded to the treatment maintainedtheir response for at least one year.

HIGH-RISK MELANOMAMA

oderna's mRNA-4157 (V940) in combination withMerck's KEYTRUDA is being evaluated for patients withresected high-risk melanoma (stage 3/4).  Regulatoryagencies have granted Breakthrough TherapyDesignation and the Priority Medicines scheme formRNA-4157 (V940) in combination with KEYTRUDAbased on the study data.

NON-SMALL CELL LUNG CANCER (NSCL C)

Following a $200M investment from BioNTech (inMarch 2023) to acquire the rights to OncoC4's antiCTLA-4 monoclonal antibody candidate, ONC-392;preliminary positive data was presented from its Phase1/2 trial. The overall response rate among evaluablepatients was 29.6%, with a disease control rate of70.4%. BNT316/ONC-392 continues to demonstrate amanageable safety profile. The company reported that"Responses were observed regardless of PD-L1 status,and among those who failed multiple lines ofimmunotherapy and chemotherapy, including PD-1 andCTLA-4 combination therapy".