This week’s oncology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.
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🧬 IDEAYA completes targeted full enrollment in OptimUM-02 [1] [US • 11 Dec 2025]
Context: Randomized Phase 2/3 in 1L HLA*A2-negative metastatic uveal melanoma, darovasertib + crizotinib vs investigator’s choice; primary endpoints PFS and OS.
Key point: Targeted 435-patient enrollment completed to enable potential full approval filing; median PFS readout anticipated 1Q26 to support potential AA.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 MAIA doses first patient in THIO-104 Phase 3 (3L NSCLC) [2] [11 Dec 2025]
Context: Open-label, up to 300 patients, ateganosine sequenced with CPI vs investigator’s choice chemotherapy; primary OS.
Key point: First patient dosed; global screening active across multiple regions.
Implication: Signals pipeline investment and modality expansion.
💉 Pumitamig (BioNTech/BMS) shows encouraging Phase 2 TNBC activity [3] [09 Dec 2025]
Context: Global randomized Phase 2, pumitamig + chemo in 1L/2L TNBC; interim analysis at 74 patients.
Key point: Reported high response rates with manageable safety; supports Phase 3 ROSETTA BREAST-01 dose selection.
Implication: May influence prescriber choice and payer reviews pending full data.
🔬 Kazia’s paxalisib shows immune-reinvigoration signals across breast cancer [4] [10 Dec 2025]
Context: SABCS posters including ex-vivo HER2+ analyses and first-patient signals from TNBC Phase 1b combo.
Key point: Data suggest disruption of CTC clusters and reduced T-cell exhaustion, with an individual patient tumor shrinkage reported.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📈 Lilly’s imlunestrant (Inluriyo) EMBER-3 update at SABCS [5] [12 Dec 2025]
Context: Phase 3 in ER+, HER2– advanced breast cancer after AI ± CDK4/6i.
Key point: Monotherapy showed improved PFS and numeric OS gain in ESR1-mutated subgroup; combo with abemaciclib improved PFS in all patients.
Implication: May influence prescriber choice and payer reviews pending full data.
🟣 Roche’s giredestrant positive in adjuvant ER+ early breast cancer [6] [10 Dec 2025]
https://www.roche.com/investors/updates/inv-update-2025-12-10
Context: lidERA Phase 3, giredestrant vs SoC endocrine therapy; >4,100 patients.
Key point: 30% iDFS risk reduction with consistent subgroup benefit; OS immature with positive trend.
Implication: May influence prescriber choice and payer reviews pending full data.
🇨🇳 Henlius serplulimab perioperative gastric cancer NDA accepted with Priority Review [7] [China • 12 Dec 2025]
https://www.henlius.com/en/NewsDetails-5670-26.html
Context: NDA for neoadjuvant serplulimab + chemo followed by adjuvant serplulimab in PD-L1–positive operable gastric cancer; supported by ASTRUM-006.
Key point: Priority Review in China for first PD-1 perioperative gastric regimen replacing adjuvant chemo with IO monotherapy.
Implication: Introduces competition that may affect pricing and formulary access.
🧪 DESTINY-Ovarian01 Phase 3 randomization started [8] [09 Dec 2025]
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202512/20251209_E.pdf
Context: Enhertu + bevacizumab vs bevacizumab as first-line maintenance in HER2-expressing advanced ovarian cancer; ~580 patients.
Key point: First patient dosed in randomized phase after safety run-in; primary PFS by BICR in HER2 IHC 3+/2+.
Implication: Signals pipeline investment and modality expansion.
✅ FDA approves AKEEGA for BRCA2-mutated mCSPC [9] [US • 12 Dec 2025]
Context: sNDA for niraparib/abiraterone dual-action tablet plus prednisone with ADT.
Key point: AMPLITUDE showed 54% rPFS risk reduction vs abiraterone + prednisone + ADT in BRCA2-mutated mCSPC.
Implication: Introduces competition that may affect pricing and formulary access.
🇨🇳 China approves next-gen TRK inhibitor zurletrectinib/zolatratinib (ICP-723) [10] [China • 11 Dec 2025]
Context: NMPA approval for NTRK fusion–positive solid tumors; pivotal registry trial cited.
Key point: Sponsor reports high ORR and intracranial activity, including activity after first-gen TRK inhibitor resistance.
Implication: Introduces competition that may affect pricing and formulary access.
Why It Matters
- ER+ breast cancer may see first adjuvant SERD with iDFS superiority, shifting long-term endocrine strategies [6].
- In ESR1-mutated MBC, SERD strategies are consolidating with oral agents and oral combos that may delay chemo [5].
- TNBC options could broaden beyond PD-(L)1 + chemo if bispecifics sustain benefit across PD-L1 strata [3].
- China’s oncology market is accelerating perioperative IO and tumor-agnostic targeted approvals, affecting global trial design and access [7][10].
- Precision urology advances with PARP + ARPI earlier in disease, adding genomic selection to mCSPC care [9].
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FAQ
What is IDEAYA’s OptimUM-02 testing and why does HLA*A2 status matter?
OptimUM-02 randomizes 1L metastatic uveal melanoma patients to darovasertib + crizotinib vs investigator’s choice. The update focuses on HLA*A2-negative patients, a group not eligible for tebentafusp. IDEAYA completed targeted 435-patient enrollment to enable a potential full approval filing [1].
How is ateganosine positioned in MAIA’s Phase 3 THIO-104?
THIO-104 evaluates ateganosine sequenced with a checkpoint inhibitor vs chemotherapy in 3L NSCLC with OS as primary endpoint. The first patient has been dosed, with global sites screening and enrolling [2].
What differentiates pumitamig in TNBC?
Pumitamig is a PD-L1×VEGF-A bispecific. Interim Phase 2 showed encouraging responses with chemo regardless of PD-L1 status, supporting the Phase 3 ROSETTA BREAST-01 program in PD-L1-negative 1L TNBC [3].
Did Lilly’s imlunestrant show overall survival benefit?
In EMBER-3, imlunestrant monotherapy showed an 11.4-month median OS improvement in ESR1-mutated patients, though the boundary for significance was not met; the combo with abemaciclib improved PFS across all patients [5].
What did Roche report for giredestrant in early breast cancer?
In lidERA, giredestrant reduced the risk of invasive disease recurrence or death by 30% vs SoC endocrine therapy, with consistent subgroup benefit and immature OS trending positive [6].
Which new approvals/filings were announced in China?
NMPA accepted with Priority Review serplulimab for perioperative PD-L1–positive operable gastric cancer [7], and approved zurletrectinib/zolatratinib (ICP-723) for NTRK fusion–positive solid tumors [10].
Entities / Keywords
IDEAYA Biosciences; darovasertib + crizotinib; uveal melanoma | MAIA Biotechnology; ateganosine/THIO; NSCLC | BioNTech; Bristol Myers Squibb; pumitamig/BNT327/BMS986545; TNBC | Kazia Therapeutics; paxalisib; PI3K/mTOR | Eli Lilly; imlunestrant/Inluriyo; abemaciclib/Verzenio; EMBER-3 | Roche; giredestrant; lidERA | Henlius; serplulimab/HANSIZHUANG/Hetronifly; gastric cancer perioperative | Daiichi Sankyo; AstraZeneca; Enhertu/trastuzumab deruxtecan; ovarian cancer maintenance | Johnson & Johnson; AKEEGA; niraparib + abiraterone; mCSPC; AMPLITUDE | InnoCare; zurletrectinib/zolatratinib/ICP-723; NTRK fusion.
References
- https://media.ideayabio.com/2025-12-11-IDEAYA-Biosciences-Completes-Targeted-Full-Enrollment-in-Randomized-Pivotal-Phase-2-3-Trial-OptimUM-02-of-Darovasertib-in-Combination-with-Crizotinib-in-First-line-HLA-A2-Negative-Metastatic-Uveal-Melanoma
- https://ir.maiabiotech.com/news-events/press-releases/detail/162/maia-biotechnology-announces-first-patient-dosed-in
- https://news.bms.com/news/details/2025/BioNTech-and-Bristol-Myers-Squibb-Present-First-Global-Phase-2-Data-for-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-Showing-Encouraging-Efficacy-in-Advanced-Triple-Negative-Breast-Cancer/default.aspx
- https://www.kaziatherapeutics.com/site/pdf/c4fa4128-0ea4-47eb-b8a7-dccc31feb881/Kazia-Therapeutics-Highlights-New-Clinical-and-Translational-Findings-Demonstrating-Paxalisibs-Ability-to-Reinvigorate-AntiTumor-Immunity-Across-Multiple-Advanced-Breast-Cancer-Populations-including-TNBC-and-HER2.pdf
- https://investor.lilly.com/news-releases/news-release-details/updated-data-lillys-inluriyotm-imlunestrant-reinforce-efficacy
- https://www.roche.com/investors/updates/inv-update-2025-12-10
- https://www.henlius.com/en/NewsDetails-5670-26.html
- https://www.daiichisankyo.com/files/news/pressrelease/pdf/202512/20251209_E.pdf
- https://www.jnj.com/media-center/press-releases/u-s-fda-approves-akeega-as-the-first-precision-therapy-for-brca2-mutated-metastatic-castration-sensitive-prostate-cancer-with-54-reduction-in-disease-progression-vs-standard-of-care
- https://www.innocarepharma.com/news/activity/cn020251211-Approval-of-Next-Generation-TRK-Inhibitor-Zurletrectinib-in-China