June 2024
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BMS ANNOUNCES POSITIVE RESULTS FOR OPDIVO AND YERVOY TO TREAT MELANOMA

MELANOMA

During ASCO 2024, BMS released the results of the NADINA trial showingneoadjuvant immunotherapy (nivolumab + ipilimumab) followed by responseguided adjuvant therapy significantly reduced recurrence and clinical eventscompared to adjuvant therapy alone in resectable stage 3 melanoma. Theneoadjuvant strategy resulted in a 68% improvement in event-free survival, with60% of patients achieving a major pathologic response.

The NADINA trial backs the results of previous studies, confirming that the dual immunotherapy provides superior responses to single-agent immunotherapy, and further supports the opportunity to diminish the burden of care for patients, as 60% of patients did not require nonstop therapy.

TRIAL FINALIZED FOR PANCREATIC CANCER TREATMENT WITH CD40 AGONIST-CHEMO COMBINATION

PANCREATIC CANCER

The phase 1b/2 OPTIMIZE-1 study, conducted byAlligator Bioscience, released positive results at ASCOfor the combination of the investigational CD40 agonistmitazalimab with modified FOLFIRINOX in previouslyuntreated metastatic pancreatic ductaladenocarcinoma. The study met its primary endpointwith a confirmed overall response rate of 40.4%, whichwas higher than historical controls. The "priming" doseof mitazalimab before chemotherapy, followed by asecond dose after, also presented a unique sequencingapproach for the combination of immuno- andchemotherapies.

The timing of mitazalimab administration in this study, presents a new approach to combining immunotherapies and chemotherapy. If additional trials can confirm positive results, this approach would likely be replicated to improve efficacy in treatments for other pancreatic tumor types.

BMS’ OPDIVO AND YERVOY RELEASE FIRST OUTCOMES OF PHASE III TRIALS FOR HEPATOCELLULAR CARCINOMA

CARCINOMA

BMS presented at ASCO 2024 to release the results ofanother trial for their dual immunotherapy, the Phase 3CheckMate-9DW trial, which demonstrated that thecombination of Opdivo (nivolumab) plus Yervoy(ipilimumab) significantly improved overall survivalcompared to lenvatinib or sorafenib as first-linetreatment for patients with unresectable hepatocellularcarcinoma (HCC). The combination showed a median overall survival of23.7 months versus 20.6 months for the control group,and more than doubled the objective response rate(36% vs 13%).

The CheckMate trial demonstrated the possibility of not only improved treatment efficacy, but also improved quality of life for patients with a 24% reduced risk of symptom deterioration compared to standard treatments.

EARLY EFFICACY INDICATIONS PRESENTED FOR J&J’S PROSTATE CANCER PIPELINE TREATMENT

PROSTATE CANCER

J&J presented the results of the first-in-human study ofJNJ-6420, a new radioligand therapy targeting hK2, atASCO, and showed promising efficacy in treatingmetastatic castration-resistant prostate cancer(mCRPC). The therapy demonstrated deep and lastingresponses after just 1-2 doses, with an objectiveresponse rate of 18% and a confirmed PSA50 responseof 44% at the 250 μCi dose level. However, the studyalso revealed some negative safety considerations,particularly interstitial lung disease (ILD) andthrombocytopenia at higher cumulative doses.

The study included patients who had received multiple prior therapies (median of 4), suggesting it could be effective even in later lines of treatment where other treatments struggle to be effective.

ROCHE’S KIM-1 BIOMARKER ANALYSIS ANNOUNCES POSITIVE RESULTS IN GUIDING ADJUVANT THERAPY

CARCINOMA

The retrospective analysis of the IMmotion010 trialpresented by Roche at ASCO 2024 suggests that KIM1 levels may serve as a promising biomarker in renalcell carcinoma (RCC). High KIM-1 levels correlatedwith beneficial effects of atezolizumab in the study,indicating its potential as a clinical tool for guidingadjuvant therapy in RCC. While the trial showed nosignificant overall difference in disease-free survivalbetween adjuvant atezolizumab and placebo, patientswith high baseline KIM-1 levels showed improveddisease-free survival with atezolizumab.

This biomarker could help identify patients most likely to benefit from adjuvant atezolizumab, increasing the targeted use of PDL-1 inhibitors. In turn, this could enhance efficacy data for various drugs, benefiting their manufacturers through enhanced marketability.

GSK RELEASES PHASE 3 TRIAL RESULTS TO IMPROVE PATIENT OUTCOMES IN MULTIPLE MYELOMA

MULTIPLE MYELOMA

The results of the DREAMM-8 phase 3 trial, presentedby GSK at ASCO, showed that Blenrep (belantamabmafodotin) in combination with pomalidomide anddexamethasone significantly improved progression-freesurvival compared to a standard of care combination inrelapsed/refractory multiple myeloma patients. TheBlenrep combination reduced the risk of diseaseprogression or death by nearly 50%, with median PFSnot reached at 21.8 months at follow-up versus 12.7months for the standard combination.

The combination of Blenrep with pomalidomide and dexamethasone nearly halved the risk of disease progression or death in relapsed/refractory myeloma patients, offering a more effective option for the approximately 176,000 new cases diagnosed globally each year.

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