Bristol-Myers Squibb's Global Strategy for MORAb-202

Bristol-Myers Squibb has been strategically reassessing its global product portfolio, resulting in the discontinuation of MORAb-202. This decision does not reflect a clinical failure of the drug, but rather a lower prioritization within the company's current range of products. Available information indicates that MORAb-202 still shows potential.

Elahere faces significant challenges due to its effectiveness being limited to patients with high FRα expression, which comprises only 35-40% of the ovarian cancer population. Additionally, concerns about Elahere's safety, particularly eye toxicity that resulted in vision impairment for one patient, have led the FDA to issue a black box warning for the drug.

Contrastingly, data from the 2022 ASCO meeting demonstrated that MORAb-202 is effective for patients with FRα expression below 50% and does not exhibit the eye toxicity seen with Elahere. Despite its discontinuation, Daiichi Sankyo remains optimistic about MORAb-202 and intends to prioritize its further development.

MORAb-202 also faces hurdles. Data presented at ASCO indicated that interstitial lung disease/pneumonia is the most common treatment-related adverse event, occurring across different dosage groups. Although there was only one case of grade 3/4 severity, the small sample size necessitates careful consideration of dose optimization and the benefit-risk balance of MORAb-202.

Bristol-Myers Squibb’s decision to discontinue MORAb-202 reflects a belief that the drug has limited competitiveness, even though it does not indicate clinical failure. The FRα-ADC market holds significant potential, but the discontinuation of MORAb-202 underscores the complexity and uncertainty in this field.

In the FRα-ADC arena, drugs like Elahere, MORAb-202, and STRO-002—once considered the "three musketeers"—each face unique challenges. STRO-002’s clinical data did not show the expected advantages and it has safety concerns such as neutropenia. With Elahere’s approval, the commercial value of STRO-002 has significantly decreased. The discontinuation of MORAb-202 highlights that investments and R&D in the FRα-ADC field need a clear-headed approach, an objective assessment of early clinical data, and significant business development transactions, along with adequate preparation to address potential risks and challenges.