December 2025 Oncology Conferences: Year-End Data from ASH, SABCS, and ESMO-IO
As 2025 draws to a close, three major oncology conferences delivered substantial clinical trial data that will inform treatment decisions throughout 2026. The American Society of Hematology Annual Meeting (December 6-9, Orlando), San Antonio Breast Cancer Symposium (December 9-12), and ESMO Immuno-Oncology Congress (December 10-12, London) collectively presented results from over 50 Phase 3 trials across hematologic malignancies and solid tumors.
This analysis examines the key clinical findings, regulatory implications, and competitive dynamics emerging from December's conference season.
Multiple Myeloma: Bispecific Antibody and CAR-T Data
MajesTEC-3 Trial Results
The Phase 3 MajesTEC-3 trial randomized 587 patients with relapsed/refractory multiple myeloma (1-3 prior lines) to teclistamab plus daratumumab subcutaneous versus investigator's choice daratumumab-based regimens (DPd or DVd). At median 34.5-month follow-up, the combination demonstrated a PFS hazard ratio of 0.17 (95% CI 0.12-0.23; P<0.0001).
The 36-month PFS rates were 83.4% versus 29.7%. Overall survival also favored the experimental arm with HR 0.46 (95% CI 0.32-0.65; P<0.0001), translating to 83.3% versus 65.0% three-year OS rates.
Response metrics:
- Overall response rate: 95.4% vs 32.1%
- Complete response or better: 81.8% vs 16.8%
- MRD negativity at 10⁻⁵ (among ≥CR): 89.3% vs 63.0%
- MRD negativity at 10⁻⁶ (among ≥CR): 87.5% vs 41.8%
Safety data showed cytokine release syndrome in 60.1% of patients in the teclistamab-daratumumab arm, though no Grade 3 or higher CRS events occurred. ICANS was reported in 1.1%. Infection rates were 96.5% versus 84.1%, with Grade 3+ infections in 54.1% versus 43.4%. Deaths occurred in 15.9% versus 33.1% of patients.
CAR-T Therapy Updates
CARTITUDE-1 extended follow-up at 61.3 months reported median PFS of 50.4 months and median OS of 60.7 months in triple-class exposed patients with at least three prior lines. Approximately one-third of patients remained progression-free at five years.
CARTITUDE-4 34-month data showed 80.5% 30-month PFS in standard-risk patients (as-treated population), with 87.3% OS at 2.5 years. All 26 patients achieving MRD-negative complete response at 12 months remained progression-free at 30 months. Early mortality was numerically higher in the ciltacabtagene autoleucel arm (14% vs 12% within 10 months), including 19 post-infusion deaths with 12 attributed to infections.
Anitocabtagene autoleucel (anito-cel, Arcellx/Gilead) iMMagine-1 Phase 2 data showed 96% ORR and 74% CR/sCR rate at median 15.9-month follow-up. The 18-month PFS was 67.4% with 88.0% OS. MRD negativity at 10⁻⁵ reached 95% in evaluable patients. CRS occurred in 86% (mostly Grade 1), with 8% ICANS (1 Grade 3). No delayed neurotoxicities were observed.
Table 1: Phase 3 Multiple Myeloma Bispecific/CAR-T Trials
| Trial | Agent | Line | N | ORR | CR/sCR | MRD⁻ (10⁻⁵) | mPFS | HR PFS | CRS Any | CRS G3+ | ICANS |
|---|---|---|---|---|---|---|---|---|---|---|---|
| MajesTEC-3 | Tec + Dara | 1-3L R/R | 587 | 95.4% | 81.8% | 89.3% | NR | 0.17 | 60.1% | 0% | 1.1% |
| CARTITUDE-4 | Cilta-cel | 1-3L R/R | 419 | 84.6% | 73% | 63% | NR | 0.29 | 76.1% | 1% | 4.5% |
| iMMagine-1 | Anito-cel | ≥3L | 117 | 96% | 74% | 95% | 18mo: 67% | — | 86% | <1% | 8% |
| MagnetisMM-30 | Elra + Iber | 2-4L | 22 | 95.5% | 45.5% | TBD | — | — | 68.2% | 0% | 9% |
| MonumenTAL-2 | Talq + Pom | R/R | 35 | 85.7% | 45.7% | — | — | — | 78% | <5% | <5% |
| LINKER-MM4 | Linvo mono | NDMM | 45 | 86% | — | 95% | — | — | ~50% | 0% | <5% |
Abbreviations: Tec=teclistamab; Dara=daratumumab; Elra=elranatamab; Iber=iberdomide; Talq=talquetamab; Pom=pomalidomide; Linvo=linvoseltamab; NR=not reached
CLL: Fixed-Duration Therapy and BTK Inhibitor Comparisons
CLL17 Trial
The Phase 3 CLL17 trial randomized 909 treatment-naïve CLL patients to continuous ibrutinib, fixed-duration venetoclax-obinutuzumab (12 cycles), or fixed-duration venetoclax-ibrutinib (15 cycles). At 34 months median follow-up, both fixed-duration arms demonstrated non-inferiority to continuous ibrutinib for PFS.
Three-year PFS rates: venetoclax-obinutuzumab 81.1%, venetoclax-ibrutinib 79.4%, ibrutinib 81.0%. Hazard ratios versus ibrutinib were 0.87 (98.3% CI 0.54-1.41) for venetoclax-obinutuzumab and 0.84 (98.0% CI 0.53-1.32) for venetoclax-ibrutinib.
MRD data showed undetectable MRD in peripheral blood reached 73.3% with venetoclax-obinutuzumab versus 47.2% with venetoclax-ibrutinib versus 0% with ibrutinib. Bone marrow uMRD rates were 62.0%, 40.0%, and 0% respectively.
Pirtobrutinib Trials
BRUIN CLL-313 compared pirtobrutinib versus bendamustine-rituximab in 282 treatment-naïve CLL patients. The 24-month PFS was 93.4% versus 70.7% (HR 0.199; 95% CI 0.107-0.367; P<0.0001). The 24-month OS rates were 97.8% versus 90.8% (HR 0.257; P=0.0261). Grade 3+ treatment-emergent adverse events occurred in 40.0% versus 67.4%.
BRUIN CLL-314 provided head-to-head Phase 3 comparison against ibrutinib, with pirtobrutinib meeting non-inferiority for ORR while demonstrating numerically superior PFS. Atrial fibrillation/flutter rates were 2.4% versus 13.5% (P<0.0001).
BTK Degrader Data
Bexobrutideg (NX-5948, Nurix) Phase 1a/1b data in 126 patients with R/R CLL showed 83% ORR with median 22.1-month PFS despite median 4 prior therapies. No new-onset atrial fibrillation was observed. Activity was maintained regardless of BTK, PLCG2, or TP53 mutation status.
Table 2: Phase 3 CLL Trials Comparison
| Trial | Regimen | N | ORR | CR | uMRD PB | uMRD BM | 3yr PFS | HR | G3+ AE | AF Rate |
|---|---|---|---|---|---|---|---|---|---|---|
| CLL17 (VO) | Ven + Obi | 303 | 84.2% | 51.5% | 73.3% | 62.0% | 81.1% | 0.87 | 59.0% | 13.9%* |
| CLL17 (VI) | Ven + Ibr | 305 | 88.5% | 46.2% | 47.2% | 40.0% | 79.4% | 0.84 | 42.9% | 23.8%* |
| CLL17 (I) | Ibrutinib | 301 | 86.0% | 8.3% | 0% | 0% | 81.0% | Ref | 28.5% | 34.6%* |
| BRUIN CLL-313 | Pirtobrutinib | 141 | 94.3% | — | — | — | 2yr: 93.4% | 0.20 | 40.0% | 1.4% |
| BRUIN CLL-313 | BR | 141 | 80.9% | — | — | — | 2yr: 70.7% | Ref | 67.4% | 0.7% |
| BRUIN CLL-314 | Pirtobrutinib | 331 | 87.0% | — | — | — | — | — | — | 2.4% |
| BRUIN CLL-314 | Ibrutinib | 331 | 78.5% | — | — | — | — | — | — | 13.5% |
| Bexobrutideg | NX-5948 | 126 | 83% | 2.1% | — | — | mPFS 22.1mo | — | 23% neut | 0% |
*Cardiac disorders overall; VO=venetoclax-obinutuzumab; VI=venetoclax-ibrutinib; I=ibrutinib; BR=bendamustine-rituximab
AML: Low-Intensity and Menin Inhibitor Combinations
PARADIGM Trial
The PARADIGM trial compared azacitidine-venetoclax versus intensive chemotherapy (7+3 or CPX-351) in fit, transplant-eligible AML patients, excluding those with FLT3 mutations, core binding factor, and NPM1-mutated patients under 60.
Event-free survival was 14.6 months versus 6.2 months (HR 0.61; P=0.017). The 30-day and 60-day mortality rates were 0% with azacitidine-venetoclax versus 3.5% and 4.7% with intensive chemotherapy. No patients in the low-intensity arm required ICU admission versus 9.8% in the intensive arm.
Menin Inhibitor Triplets
Revumenib combined with decitabine-cedazuridine and venetoclax in newly diagnosed NPM1-mutated or KMT2A-rearranged AML achieved 86% ORR, 76% CR rate, and 100% MRD negativity in responders. Ziftomenib triplet combinations with venetoclax and azacitidine in newly diagnosed NPM1-mutated patients produced 86% composite CR with 73% CR at median age 75 years.
In the relapsed/refractory setting, response rates varied by molecular subtype. With ziftomenib triplet combinations, NPM1-mutated patients achieved 65% ORR and 48% composite CR, while KMT2A-rearranged patients achieved 41% ORR and 28% composite CR. Venetoclax-naïve patients showed substantially better responses: 83% ORR in NPM1m and 70% in KMT2Ar.
Table 3: AML Menin Inhibitor Efficacy
| Agent | Trial | Population | N | CR+CRh | MRD⁻ | mOS | DLT | Key Toxicities |
|---|---|---|---|---|---|---|---|---|
| Revumenib mono | AUGMENT-101 | R/R NPM1m | 64 | 23% | 64% | — | 5% | QTc 21%, DS 25% |
| Revumenib triplet | SAVE | ND NPM1m/KMT2Ar | 21 | 81% | 100% | NR | 0% | DS 13%, FN 13% |
| Revumenib + IC | Phase 1 | ND KMT2Ar/NPM1m | 26 | 92% | 86% | NR | 0% | FN 46% |
| Ziftomenib mono | KOMET-001 | R/R NPM1m | 92 | 22% | 61% | 18.4mo | <5% | DS 25% |
| Ziftomenib triplet | KOMET-007 | ND NPM1m | 37 | 86% | 68% | NR | 0% | FN 33%, DS 12% |
| Ziftomenib triplet | KOMET-007 | R/R NPM1m | 48 | 48% | — | — | 0% | Thromb 36% |
| Ziftomenib triplet | KOMET-007 | R/R KMT2Ar | 32 | 28% | — | — | 0% | — |
DS=differentiation syndrome; FN=febrile neutropenia; IC=intensive chemotherapy; NR=not reached
Gene Therapy for Sickle Cell Disease
Casgevy Pediatric Data
Vertex presented first pediatric data for exagamglogene autotemcel (Casgevy) in children ages 5-11. In sickle cell disease, 100% of evaluable patients (4/4) achieved VOC-freedom for ≥12 consecutive months, with longest VOC-free duration reaching 24 months. In adults and adolescents with longer follow-up, 100% of 45 patients achieved VF12, with mean VOC-free duration of 35.3 months (up to 67.7 months).
In transfusion-dependent beta-thalassemia, 98.2% (55/56) achieved transfusion independence for ≥12 months, with mean duration of 41.4 months. Pediatric TDT patients showed 100% (6/6) transfusion independence among evaluable patients. One fatal veno-occlusive disease occurred in a pediatric TDT patient, attributed to busulfan conditioning. No malignancies have been reported.
Lyfgenia Update
Lovotibeglogene autotemcel (Lyfgenia) commercial data showed 115 patients treated across Lyfgenia and Zynteglo programs, with 88% achieving complete VOC resolution. The malignancy signal remains: 2 patients developed AML (both died) and 1 patient developed MDS, all from earlier manufacturing cohorts. Lifelong monitoring with CBC every six months for at least 15 years is required.
Pociredir Oral Therapy
Pociredir (Fulcrum Therapeutics), an oral EED inhibitor, showed mean HbF increase of 9.9% (from 7.1% to 16.9%) at Week 6 with the 20mg dose. 58% of patients achieved ≥20% HbF. Hemolysis markers improved: 37% decrease in indirect bilirubin, 37% reduction in LDH, 33% decrease in reticulocytes. 50% of patients reported zero VOCs during treatment, with no treatment-related serious adverse events.
Table 4: Gene Therapy for Hemoglobinopathies
| Therapy | Company | Mechanism | Approval | VOC-Free | TI Rate (TDT) | HbF | Malig Signal | Price |
|---|---|---|---|---|---|---|---|---|
| Casgevy | Vertex/CRISPR | BCL11A CRISPR | Dec 2023 | 100% | 98.2% | >40% | None | $2.2M |
| Lyfgenia | Genetix | Lentiviral | Dec 2023 | 88% | — | HbAT87Q | 2 AML, 1 MDS | $3.1M |
| Zynteglo | Genetix | Lentiviral | Aug 2022 | — | 89% | — | Low | ~$2.8M |
| Pociredir | Fulcrum | Oral EED inh | Phase 1b | 50% (0 VOC) | — | 16.9% | None | TBD |
SABCS 2025: Breast Cancer Data
monarchE Overall Survival
The monarchE trial reported first statistically significant OS benefit with a CDK4/6 inhibitor in adjuvant breast cancer. At 76.2-month median follow-up, abemaciclib plus endocrine therapy demonstrated OS HR of 0.842 (95% CI 0.722-0.981; P=0.027) versus endocrine therapy alone in HR+/HER2- node-positive high-risk early breast cancer.
Seven-year OS rates were 86.8% versus 85.0% (1.8% absolute difference). Seven-year iDFS was 77.4% versus 70.9% (6.5% absolute difference; HR 0.734). Seven-year DRFS was 80.0% versus 74.9% (5.1% absolute difference).
Subgroup analyses showed tumors <2cm derived greatest benefit (HR 0.48; 95% CI 0.358-0.646). Premenopausal women showed 42.2% risk reduction (HR 0.578; 95% CI 0.441-0.758). Benefit was consistent regardless of Ki-67 status: Ki-67 ≥20% HR 0.66; Ki-67 <20% HR 0.70.
Giredestrant (lidERA Trial)
The Phase 3 lidERA trial randomized 4,170 patients with stage I-III HR+/HER2- early breast cancer to giredestrant versus physician's choice endocrine therapy. iDFS HR was 0.70 (95% CI 0.57-0.87; P=0.0014). Three-year iDFS was 92.4% versus 89.6%. DRFI HR was 0.69. Interim OS showed HR 0.79 (data 31% mature).
Treatment discontinuation was lower with giredestrant (5.3% vs 8.2%). Bradycardia occurred in 11.3% versus 3.2%, mostly Grade 1 and asymptomatic.
Imlunestrant (EMBER-3)
Extended EMBER-3 follow-up showed median OS of 34.5 months versus 23.1 months (HR 0.60; P=0.0043) in ESR1-mutated patients—an 11.4-month survival advantage. The imlunestrant-abemaciclib combination achieved median PFS of 10.9 months versus 5.5 months for imlunestrant monotherapy (HR 0.59; P<0.0001), delaying time to chemotherapy by more than one year regardless of ESR1 mutation status.
Camizestrant (SERENA-6)
SERENA-6 data validated ctDNA-guided therapy switching. Patients who switched to camizestrant upon detection of emergent ESR1 mutations while on first-line AI plus CDK4/6 inhibitor achieved median PFS of 16.0 months versus 9.2 months (HR 0.44; P<0.0001). Two-year PFS was 29.7% versus 5.4%.
Table 5: CDK4/6 Inhibitor Adjuvant Trials
| Trial | Agent | N | Risk Population | iDFS HR (95% CI) | Abs iDFS | OS HR | P-value | Key Toxicities |
|---|---|---|---|---|---|---|---|---|
| monarchE | Abemaciclib | 5,637 | N+, high-risk | 0.734 (0.657-0.820) | 6.5% (7yr) | 0.842 | P=0.027 | Diarrhea 76%, neut 45% |
| NATALEE | Ribociclib | 5,101 | Stage II-III | 0.716 | 4.9% (4yr) | 0.800 | P=0.026 nom | Neutropenia, QTc |
| PENELOPE-B | Palbociclib | 1,250 | Post-neoadj residual | 0.93 (0.74-1.17) | NS | — | NS | Neutropenia |
| PALLAS | Palbociclib | 5,796 | Stage II-III | 0.96 (0.81-1.14) | NS | — | NS | Neutropenia |
Table 6: Oral SERD/PROTAC Competitive Landscape
| Agent | Company | Mechanism | Phase | Key Trial | Setting | Efficacy HR | ESR1m Data | Status |
|---|---|---|---|---|---|---|---|---|
| Elacestrant | Stemline | Oral SERD | Approved | EMERALD | 2L+ mBC | PFS 0.70 | mPFS 3.8 vs 1.9 mo | FDA Jan 2023 |
| Imlunestrant | Eli Lilly | Oral SERD | Approved | EMBER-3 | 2L+ mBC | PFS 0.62 | mPFS 5.5 vs 3.8 mo | FDA Sept 2025 |
| Camizestrant | AstraZeneca | Oral SERD | Phase 3 | SERENA-6 | ctDNA-switch | PFS 0.44 | mPFS 16.0 vs 9.2 mo | Filing H1 2026 |
| Vepdegestrant | Arvinas/Pfizer | PROTAC | Phase 3 | VERITAC-2 | 2L+ mBC | PFS 0.57 | mPFS 5.0 vs 2.1 mo | PDUFA June 2026 |
| Giredestrant | Roche | Oral SERD | Phase 3 | lidERA | Adjuvant | iDFS 0.70 | — | Filing 2026 |
HER2+ Breast Cancer
DESTINY-Breast05
The DESTINY-Breast05 trial compared trastuzumab deruxtecan versus T-DM1 in HER2+ patients with residual invasive disease after neoadjuvant therapy. The iDFS HR was 0.47 (95% CI 0.34-0.66; P<0.0001). Three-year iDFS was 92.4% versus 83.7% with T-DM1. Distant recurrence was 5.1% versus 9.9% (HR 0.49).
ILD occurred in 9.6% of T-DXd patients, with two Grade 5 events (0.2%).
DESTINY-Breast09
First-line metastatic data showed T-DXd plus pertuzumab achieved PFS HR of 0.56 (95% CI 0.44-0.71; P<0.0001) versus taxane-trastuzumab-pertuzumab. Median PFS was 40.7 months versus 26.9 months. ORR was 85.1% versus 78.6%; CR rates were 15.1% versus 8.5%. FDA approval for this indication occurred December 15, 2025.
HER2CLIMB-05
HER2CLIMB-05 tested tucatinib plus trastuzumab-pertuzumab as first-line maintenance. PFS HR was 0.641 (P<0.0001). Median PFS was 24.9 versus 16.3 months. In HR-negative disease, HR was 0.554 (P=0.0002); in HR-positive disease, HR was 0.725 (P=0.0389). CNS-PFS nearly doubled: 8.5 versus 4.3 months.
Table 7: HER2+ Breast Cancer Trials
| Trial | Agent | Setting | N | mPFS | HR (95% CI) | ORR | CNS Activity | ILD Rate |
|---|---|---|---|---|---|---|---|---|
| DESTINY-Breast05 | T-DXd | Adj residual | 1,635 | 3yr iDFS 92.4% | 0.47 (0.34-0.66) | — | Fewer CNS mets | 9.6% |
| DESTINY-Breast09 | T-DXd + P | 1L mBC | 1,157 | 40.7 mo | 0.56 (0.44-0.71) | 85.1% | Yes | Consistent |
| HER2CLIMB-05 | Tuc + HP | Maint | 654 | 24.9 mo | 0.641 | — | CNS-PFS 8.5mo | — |
| KATHERINE | T-DM1 | Adj residual | 1,486 | 3yr iDFS 88.3% | 0.50 | — | No | Low |
Triple-Negative Breast Cancer
TROPION-Breast02
TROPION-Breast02 compared datopotamab deruxtecan versus chemotherapy in first-line PD-L1-negative TNBC. Median PFS was 10.8 months versus 5.6 months (HR 0.57; 95% CI 0.47-0.69; P<0.0001). Median OS was 23.7 months versus 18.7 months (HR 0.79; 95% CI 0.64-0.98; P=0.0291). ORR was 62.5% versus 29.3%.
ASCENT-04
ASCENT-04 tested sacituzumab govitecan plus pembrolizumab versus chemotherapy-pembrolizumab in first-line PD-L1-positive TNBC. Median PFS was 11.2 months versus 7.8 months (HR 0.65; 95% CI 0.51-0.84; P<0.001). Median duration of response was 16.5 versus 9.2 months. Neutropenia occurred in 65% (43% Grade 3-4). Treatment discontinuation was 12% versus 31%.
TNBC Prevention Vaccine
The α-lactalbumin vaccine (Anixa Biosciences/Cleveland Clinic) Phase 1 data in TNBC survivors and BRCA mutation carriers showed 74% of participants achieved immune responses. No serious adverse events occurred; only mild injection-site reactions were reported. Phase 2 trials are planned.
ESMO-IO 2025: Immunotherapy Data
IMA203CD8 TCR T-Cell Therapy
Immatics presented Phase 1a data for IMA203CD8 (PRAME-targeting TCR T-cell therapy) in 78 patients across melanoma, ovarian carcinoma, and synovial sarcoma. Confirmed ORR was 36% with best response ORR of 46%. Disease control rate at Week 6 was 84%. Median duration of response was 9.2 months. Seven responses remained ongoing for ≥1 year.
CRS distribution: Grade 1 (35%), Grade 2 (50%), Grade 3 (9%), Grade 4 (1%). No treatment-related deaths occurred.
SHR-1701 in Gastric Cancer
SHR-1701 (PD-L1/TGF-β bifunctional antibody, Hengrui) showed benefit in high-risk gastric/GEJ cancer. In 551 patients with high-risk features, median OS was 14.4 months versus 10.1 months (HR 0.62; 95% CI 0.49-0.78). Patients with liver metastases showed median OS of 16.8 versus 10.3 months (HR 0.46).
Neoadjuvant Melanoma
NADINA 2-year update confirmed 18-month EFS of 80.8% with neoadjuvant ipilimumab-nivolumab versus 53.9% with adjuvant nivolumab alone (HR 0.32). SWOG S1801 showed 3-year EFS of 68% versus 56% (HR 0.67) with neoadjuvant pembrolizumab.
Table 8: TCR T-Cell Therapy Solid Tumor Data
| Agent | Target | Company | Phase | Tumor Types | N | ORR | mDOR | CRS Any | CRS G3+ |
|---|---|---|---|---|---|---|---|---|---|
| IMA203CD8 | PRAME | Immatics | 1a | MEL, OC, SS | 78 | 46% | 9.2 mo | 95% | 10% |
| Afami-cel | MAGE-A4 | Adaptimmune | Approved | Synovial sarcoma | 44 | 43.2% | 6.0 mo | 75% | 2% |
| TAEST16001 | NY-ESO-1 | — | 1 | Soft tissue | 12 | 41.7% | 13.1 mo | Low | Low |
MEL=melanoma; OC=ovarian carcinoma; SS=synovial sarcoma
Corporate and Deal Activity
GSK-IDEAYA Termination
GSK terminated its IDEAYA partnership, returning Werner Helicase (IDE275) and Pol Theta (IDE705) programs to IDEAYA effective March 9, 2026. The original 2020 deal included $100 million upfront plus $20 million equity. IDEAYA maintains cash runway into 2030.
Other M&A
Ipsen completed acquisition of ImCheck Therapeutics, expanding its immunotherapy pipeline. Natera acquired Foresight Diagnostics for $275M plus $175M milestones, expanding MRD ctDNA capabilities.
Other notable 2025 oncology deals: J&J acquired Halda for $3B (prostate/lung); Sanofi acquired Blueprint for $9.5B; GSK acquired IDRx for $1.15B (GIST); BMS entered $1.5B license with BioNTech for PD-1xVEGF bispecific.
Table 9: December 2025 Corporate Activity
| Companies | Deal Type | Assets | Terms | Rationale |
|---|---|---|---|---|
| Ipsen → ImCheck | Acquisition | IO pipeline | Undisclosed | Expand IO |
| Natera → Foresight | Acquisition | MRD ctDNA | $275M + $175M | Precision oncology |
| J&J → Halda | Acquisition | Prostate/lung | $3B | Oncology growth |
| BMS ↔ BioNTech | License | PD-1xVEGF | $1.5B + $7.6B miles | Bispecific access |
| Sanofi → Blueprint | Acquisition | Ayvakit | $9.5B | Oncology/rare |
| GSK → IDRx | Acquisition | IDRX-42 | $1.15B | GIST precision |
| AZ → EsoBiotec | Acquisition | In vivo CAR-T | $425M + miles | Cell therapy |
Table 10: Key 2026 PDUFA Dates
| Drug | Company | Indication | PDUFA Date | Priority Review |
|---|---|---|---|---|
| Vepdegestrant | Arvinas/Pfizer | ESR1m HR+/HER2- mBC | June 5, 2026 | Fast Track |
| Camizestrant | AstraZeneca | ESR1m HR+/HER2- mBC | H1 2026 est | — |
| 177Lu-edotreotide | ITM | GEP-NETs | Aug 28, 2026 | Standard |
| Zidesamtinib | Nuvalent | ROS1+ NSCLC | Sept 18, 2026 | Standard |
| Anito-cel | Arcellx/Gilead | R/R MM | 2026 est | Expected |
| T-DXd + THP | Daiichi/AZ | Neoadj HER2+ BC | May 18, 2026 | Standard |
2026 Outlook
The December 2025 conference data positions several therapeutic classes for regulatory decisions and market entry in 2026.
In multiple myeloma, the MajesTEC-3 results will likely lead to regulatory submissions for teclistamab-daratumumab in earlier lines. The differentiated safety profile of anito-cel may enable broader CAR-T utilization if approved.
In breast cancer, the oral SERD class will see increased competition as camizestrant and vepdegestrant approach regulatory decisions. The monarchE OS data supports continued CDK4/6 inhibitor use in high-risk adjuvant populations. T-DXd has established itself as a platform therapy across HER2+ and HER2-low disease.
In CLL, fixed-duration regimens may shift standard practice away from continuous BTK inhibition, particularly given the cardiovascular safety data favoring newer agents.
The AML menin inhibitor triplets represent a potential shift toward low-intensity curative approaches in molecularly defined subsets.
Gene therapy for hemoglobinopathies continues to demonstrate durable benefit, though the safety contrast between Casgevy and Lyfgenia will influence market dynamics.
The information in this article is provided for informational purposes only. The author is not a lawyer, financial advisor, or licensed medical professional. This content does not constitute investment, legal, or medical advice.
Member discussion