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Bristol's CheckMate 067 Revives Debate On Rationing Yervoy/Opdivo Combo

 
• By Emily Hayes

Yervoy/Opdivo combo proves significant survival benefit over Yervoy alone in Phase III frontline melanoma study, but is on par with Opdivo alone in patients with higher PD-L1 expression.

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Survival data for Bristol-Myers Squibb Co.'s Yervoy/Opdivo combination in the CheckMate 067 study in frontline melanoma reinforce the regimen's potency, but also revive a debate about whether the regimen should be reserved for select subsets of patients, with others getting enough benefit from Opdivo alone or other treatment options.

The combination of Yervoy (ipilimumab), a CTLA-4 inhibitor, and Opdivo (nivolumab), a PD-1 inhibitor, received accelerated approval from FDA in frontline metastatic melanoma in October 2015 based on an improvement in the trial's co-primary endpoint of progression-fee survival

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First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

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In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.