Genmab Challenges Elahere in Endometrial Cancer, Inavolisib Boosts Survival in Breast Cancer
Published about 1 month ago • 1 min read
Genmab’s Endometrial Cancer Candidate Outperforms Expectations in Elahere-Competitive Space
Context: The antibody-drug conjugate (ADC) market in gynecologic cancers is heating up, particularly following the success of ImmunoGen’s Elahere in ovarian cancer.
What's New? Genmab and Seagen's ADC, currently in Phase 2, showed a 36% response rate in recurrent endometrial cancer, exceeding internal forecasts and prompting an accelerated push into Phase 3 development.
Why it Matters? The results position Genmab as a serious competitor in gynecologic ADCs and signal broader market momentum beyond ovarian indications.
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Inavolisib Combination Improves Overall Survival in PIK3CA-Mutated Breast Cancer
Context: PIK3CA mutations drive resistance in HR+/HER2- breast cancer, making targeted therapy combinations a key strategy.
What's New? A Phase 3 trial showed that inavolisib plus palbociclib and fulvestrant significantly extended overall survival in PIK3CA-mutated, HR+/HER2- advanced breast cancer, offering a potential best-in-class PI3K approach.
Why it Matters? These data strengthen the case for next-generation PI3K inhibitors and may offer a more tolerable and effective alternative to alpelisib-based regimens.
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FDA Advisory Committee Rejects Broader Use of Pfizer’s Talzenna in Prostate Cancer
Context: Talzenna (talazoparib) is approved for BRCA-mutated prostate cancer in combination with Xtandi, but Pfizer sought to expand use into an all-comers mCRPC population.
What's New? The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously against the label expansion, citing lack of benefit in non-HRR-mutated subgroups and risk of misleading use in biomarker-negative patients.
Why it Matters? The decision underscores the regulatory emphasis on biomarker-driven approvals and limits Talzenna’s market growth in prostate cancer beyond genetically defined subsets.
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Dual-Target ADC Combo Puxitatug + Samrotecan Shows Early Promise in Endometrial Cancer
Context: Treatment options for recurrent endometrial cancer remain limited, with immunotherapy and ADCs under active investigation.
What's New? In a small early-phase study, a combo of anti-TROP2 ADC samrotecan and anti-CD47 puxitatug led to a 44% response rate in heavily pretreated endometrial cancer patients, with manageable safety signals.
Why it Matters? These data suggest potential for dual-modality ADC regimens to overcome resistance mechanisms and expand treatment durability in gynecologic oncology.
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Regeneron Acquires 23andMe Research Division for $256M in Bankruptcy Auction Context: As 23andMe navigates Chapter 11 proceedings, key assets tied to its vast genomic database and pharma partnerships have drawn industry attention. What's New? Regeneron has secured a $256 million deal to acquire 23andMe’s therapeutics subsidiary, aiming to leverage the platform’s extensive genotypic and phenotypic data to fuel its precision medicine pipeline. Why it Matters? This acquisition gives Regeneron a...
about 1 month ago • 1 min read
Cullinan and Taiho Reveal Positive NSCLC Data Ahead of FDA Filing Context: Cullinan Oncology and Taiho are developing CLN-081, an EGFR exon 20 insertion–targeting therapy for NSCLC—a mutation subtype with limited approved options. What's New? At ASCO, the companies presented data showing a response rate of 41% and a 12.7-month median duration of response for CLN-081. The results are expected to support an FDA submission in the second half of 2024. Why it Matters? These findings position...
about 1 month ago • 1 min read
Roche’s Itovebi Cuts Risk of Death by 33% in HER2-Positive Breast Cancer Context: HER2-positive breast cancer remains an aggressive subtype despite advances in targeted therapies. What's New? In updated data presented at ASCO, Roche’s anti-HER2 therapy Itovebi (trastuzumab duocarmazine) reduced the risk of death by 33% in pretreated HER2-positive breast cancer, significantly improving overall survival compared to standard therapies. Why it Matters? This reinforces Itovebi’s growing role in...
about 1 month ago • 1 min read