Genmab to acquire Merus

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Kickstart your research with key insights from a selection of transcripts available within our Third Bridge Library below.

Merus vs Bicara Therapeutics in HNSCC – American Society of Clinical Oncology Data Review – Head & Shoulders Above the Rest?

Transcript key insights: 

• First-line standard of care is either pembro monotherapy or pembro plus chemotherapy, depending on patient's clinical presentation. Pembro mono is used in 20-30% of first-line patients. Despite this, pembro mono is an appropriate control arm, as investigators wouldn't put heavily advanced patients into trials. Thus, there is selection bias for healthier patients who adequately respond to pembro mono. Specialist's experience lines up with KEYNOTE-048
• Peto plus pembro data is "very compelling", with response rates maintained in larger sample size. Specialist expects 55-60% overall response rate in HPV-negative patients in phase 3. Cautions efficacy in HPV-positive patients is less compelling, noting overall response rate fell from 75% to 50% with four additional patients included in the analysis. Believes HPV-positive overall response rate will fall to 25-30% in phase 3
• Peto plus pembro efficacy is more similar than different to ficera plus pembro's, as demonstrated by similar progression-free survival and overall response rate. 12-month OS difference is "not surprising". There's a survival advantage to having HPV-positive patients in peto's data. Believes mOS in HPV-negative patients will be ultimately comparable between the two agents in combination with pembro, offering 9-10-month OS benefit over pembro monotherapy. Doesn't think ficera's potentially deeper responses will correlate with OS
• While efficacy looks comparable, cautions ficera's bleeding risk shown in phase 1 is something to watch out for in phase 3. Ficera's more frequent dosing would be disadvantageous, although Bicara may be looking to address this in as-of-yet undefined phase 3 dosing schema. Most importantly, peto seems poised to be first to market, which would represent significant first-mover advantage in absence of any material efficacy difference
• Expects peto plus pembro to be approved, although approval may be limited to HPV-negative patients. Even if approved for all-comers, would only be used in HPV-negative patients, given HPV vaccine trials "are much more promising", with data suggesting higher responses and better tolerability than can be expected from peto plus pembro in a larger sample size of HPV-positive patients

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Bicara Therapeutics – Bispecifics for HNSCC & Trial Design Nuances vs Merus's Petosemtamab

Transcript key insights: 

• Standard of care in recurrent/metastatic HNSCC is highly variable, but KEYNOTE-048 remains quotable gold standard, as "vast majority" still received immunotherapy alone
• Ficerafusp data is "frankly impressive […] I would say that the Bicara drug may turn out to be equal to a little bit better in the HPV-negative population […] I'd be surprised if it were like 30%, 40% better"
• Deep responses aren’t terribly important to specialist, as they're not greatly predictive of long-term survival. Specialist thinks 12-month OS rates are highly predictive of subsequent timelines in HNSCC trials, contradicting Bicara CEO’s commentary
• Stratification of HPV-positive and HPV-negative patient outcomes in Merus' phase 3 will be extremely important in comparison with ficerafusp. Early phase data comparison is impossible to call without further delineation
• Merus' all-comers approach increases chances of success by including a broader patient population, while Bicara's single-group trial provides cleaner data for judging drug activity

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