Topic
Oncology: latest medical news
Cancer drugs, trials, vaccines and approvals.
Patient dies in Bristol Myers Squibb autoimmune CAR-T trial
Source: STAT
STAT reports a patient death in a Bristol Myers Squibb trial of CAR-T therapy for an autoimmune condition, and asks where the safety bar should sit for these studies (full story is STAT+).
Why it mattersAutoimmune patients are not facing the same risk-benefit trade-off as patients with refractory cancer, so serious events in this setting will shape regulator, IRB and sponsor tolerance for the whole CAR-T-in-autoimmunity field.
Moderna, Merck shares fall on eagerly anticipated cancer vaccine results
Source: BioPharma Dive
In a landmark melanoma study, the Moderna/Merck personalized cancer vaccine (intismeran) plus Keytruda cut the risk of relapse or death by 42%, a result that met Wall Street expectations but triggered a 'sell-the-news' share drop.
Why it mattersThis is a key test of individualized mRNA cancer vaccines in the adjuvant setting; oncologists will want the full ESMO data, and regulators a first look at a new class with its own manufacturing and safety questions.
Most cancer drugs approved by European regulators lack a high clinical benefit, analysis finds
Source: STAT
A new analysis finds that most new cancer medicines approved by European regulators over a recent four-year period do not offer high clinical benefit (full story is STAT+).
Why it mattersThis adds pressure on approval and reimbursement standards in oncology and is relevant to HTA, market-access and benefit-risk discussions for new oncology filings.
Genmab shares rise after Rina-S hits PFS and OS in phase 3 ovarian cancer trial
Source: RTTNews
Genmab shares gained about 10% on Friday after the phase 3 RAINFOL-02 trial of rinatabart sesutecan (Rina-S) in platinum-resistant ovarian cancer met its primary progression-free survival endpoint and key secondary overall survival endpoint, per RTTNews; Genmab reported a 71% reduction in risk of progression or death and 57% reduction in risk of death versus investigator's-choice chemotherapy.
Why it mattersPlatinum-resistant ovarian cancer has few effective options, and an OS benefit for an FRα-targeted ADC is a strong regulatory and commercial signal; Genmab plans to discuss the data with regulators. Not investment advice.
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