sofetabart mipitecan (LY4170156) / Eli Lilly - LARVOL DELTA

Results from the first-in-human phase I study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC) (ESMO 2025) - P1 | "LY4170156 demonstrated preclinical in vivo efficacy across all FRα expression levels and mirvetuximab soravtansine-gynx (mirv) resistant ovarian models, as well as across multiple tumor types. Conclusions LY4170156 was well-tolerated among PROC pts with promising clinical activity across all FRα expression levels and regardless of prior mirv treatment. Updated results from the PROC dose optimization cohort (n=61) and efficacy among all FRα expression levels will be presented."

First-in-human • P1 data • Platinum resistant • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (Sofe-M) in Platinum-Resistant Ovarian Cancer (PROC), and Sofe-M plus Bevacizumab (Bev) in Platinum-Sensitive Ovarian Cancer (PSOC). (ESMO 2026) - No abstract available

P3 data • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor

Model-Informed Phase 3 Dose Selection for Antibody-Drug Conjugate (ADC) Sofetabart Mipitecan (Sofe-M): First Prospective Application of a Clinical Utility Index (CUI) (ESMO 2026) - No abstract available

ADC • Clinical • P3 data • Oncology

LOXO-FRA-24001: A Study of Sofe-M in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=575 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Apr 2027 ➔ Jun 2029 | Trial primary completion date: Feb 2027 ➔ Jun 2029

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

Efficacy and safety of sofetabart mipitecan (Sofe-M), a folate receptor alpha (FRα) targeting antibody drug conjugate (ADC), plus bevacizumab (bev) in recurrent platinum (plat) sensitive ovarian cancer (PSOC) (ESMO 2026) - No abstract available

ADC • Clinical • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

SOFETABART MIPITECAN, A FOLATE RECEPTOR ALPHA-TARGETED ANTIBODY-DRUG CONJUGATE IN FRΑ-HIGH, MIRVETUXIMAB SORAVTANSINE-NAÏVE PLATINUM-RESISTANT OVARIAN CANCER; RESULTS FROM A PHASE 1 STUDY (IGCS 2026) - P1, P3 | "Fifty-four FRα-high, MIRV-naïve PROC patients received Sofe-M at 2 mg/kg (n=15), 3mg/kg (n=3), 4mg/kg (n=34), and 6mg/kg (n=2). Median age was 64years (range, 37–89). Median prior therapies: 4 (range, 1-9)."

ADC • P1 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Results from the first-in-human phase 1 study of LY4170156, a folate receptor alpha-targeting antibody drug conjugate, in ovarian cancer patients previously exposed to antibody drug conjugate therapy (ESGO 2026) - "Mirvetuximab soravtansine-gynx (MIRV) improved clinical outcomes in platinum-resistant ovarian cancer (PROC) with high FRα expression. Conclusion LY4170156 demonstrated encouraging clinical activity and was well-tolerated in prior ADC-exposed PROC patients. Comparable responses to the whole population were observed in MIRV and other ADC-exposed patients, supporting the efficacy and broad therapeutic utility of LY4170156 in PROC."

Clinical • First-in-human • P1 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC • TOP1

Sofetabart mipitecan (Sofe-M) in patients (pts) ≥65 y with platinum-resistant and -sensitive ovarian cancer (PROC/PSOC) from the first-in-human phase 1 study (ESMO 2026) - No abstract available

Clinical • First-in-human • P1 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Encore: Updated results from the first-in-human phase 1 study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha (FRα) in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC) (SGO 2026) - No abstract available

ADC • First-in-human • P1 data • Platinum resistant • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Sofetabart mipitecan: Primary completion of P3 FRAmework-01 trial (NCT07213804) for ovarian neoplasm in Nov 2028 (Eli Lilly) - Q2 2026 Results: Completion of P3 FRAmework-01 trial for ovarian neoplasm in Aug 2031

Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer

Update from the phase I study of sofetabart mipitecan (Sofe-M), an antibody-drug conjugate (ADC) targeting folate receptor alpha (FR?) in advanced ovarian cancer (OC) (ESMO-Gynae 2026) - P1, P3 | "Prior Tx with mirvetuximab soravtansine (mirv) and other non-FRα Topo 1 ADCs was allowed. Table: 141P ORR in efficacy evaluable pts Conclusions Sofe-M was well tolerated and resulted in durable clinical efficacy in heavily pretreated pts with HGOC, regardless of FRα level or prior mirv. Phase III study FRAmework-01 (NCT07213804) is open and enrolling, evaluating Sofe-M monotherapy in PROC and combined with bevacizumab in platinum-sensitive OC."

ADC • Metastases • P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Initial results from a first-in-human phase 1 study of LY4170156, an ADC targeting folate receptor alpha (FRα), in advanced ovarian cancer and other solid tumors. (ASCO 2025) - P1 | "Pts with prior ADCs targeting FRα with payloads other than topo-I (including mirvetuximab soravtansine-gynx [mirv]) were allowed... LY4170156 was well-tolerated with encouraging clinical activity among HGSOC pts, including those with FRα expression < 75% and those with prior mirv. Randomized dose optimization is ongoing and updated data will be presented."

Metastases • P1 data • Anemia • Fatigue • Febrile Neutropenia • High Grade Serous Ovarian Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer (clinicaltrials.gov) - P3 | N=1630 | Recruiting | Sponsor: Eli Lilly and Company | N=1080 ➔ 1630 | Trial primary completion date: Apr 2028 ➔ Nov 2028

Enrollment change • Platinum resistant • Platinum sensitive • Trial primary completion date • Breast Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Results from the first-in-human phase 1 study of LY4170156, an antibody drug conjugate (ADC) targeting folate receptor alpha (FRa) in recurrent platinum resistant high-grade serous ovarian cancer (HGSOC) (DKK 2026) - "LY4170156 demonstrated preclinical in vivo efficacy across all FRα expression levels and mirvetuximab soravtansine-gynx (mirv) resistant ovarian models, as well as across multiple tumor types. LY4170156 was well-tolerated among PROC pts with promising clinical activity across all FRα expression levels and regardless of prior mirv treatment. Updated results from the PROC dose optimization cohort (n=61) and efficacy among all FRα expression levels will be presented."

First-in-human • Late-breaking abstract • P1 data • Platinum resistant • Febrile Neutropenia • High Grade Serous Ovarian Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

FRAmework-01: A two-part phase 3 study of sofetabart mipitecan versus chemotherapy or mirvetuximab soravtansine in platinum-resistant ovarian cancer (PROC), and sofetabart mipitecan plus bevacizumab versus platinum-based chemotherapy plus bevacizumab in platinum-sensitive ovarian cancer (PSOC). (ASCO 2026) - P3 | " In Part A, 530 participants with PROC who received ≤3 prior lines of systemic cytotoxic therapy (or ≤4 lines if MIRV was included), will be randomized in a 1:1 ratio to receive either sofetabart mipitecan, or the investigator's choice (IC) of chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) or MIRV (if eligible per local label). In Part B, 550 participants with PSOC who received ≤2 prior lines of systemic cytotoxic therapy and had disease progression either during or within six months of completing treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi), will be randomized in a 1:1 ratio to receive either sofetabart mipitecan plus bevacizumab (bev), or the IC of carboplatin-based chemotherapy (paclitaxel, PLD, or gemcitabine) plus bev...Study parts will be conducted separately, and statistical analyses will be performed independently. Trial Status: The study is actively enrolling participants in Part A and B...."

P3 data • Platinum resistant • Platinum sensitive • Oncology • Ophthalmology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC

J5E-MC-JZXB: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants with Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (FRAmework-01) (clinicaltrialsregister.eu) - P2/3 | N=311 | Not yet recruiting | Sponsor: Eli Lilly & Co.

New P2/3 trial • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

LOXO-FRA-24001: A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=495 | Recruiting | Sponsor: Eli Lilly and Company | N=223 ➔ 495

Enrollment change • First-in-human • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

LY4170156, an antibody-drug conjugate targeting folate receptor alpha, exhibits enhanced antitumor activity in combination with standard-of-care therapies in preclinical ovarian cancer models (AACR 2026) - P1, P3 | "In preclinical studies, LY4170156 was active against various FRα-expressing tumors1, including those with low/moderate (0 - <75%)2 FRα expression.1 The Phase 1 trial (NCT06400472) indicated that LY4170156 was well-tolerated and resulted in durable clinical efficacy in heavily pretreated patients with platinum-resistant ovarian cancer (PROC), regardless of FRα levels or prior mirvetuximab soravtansine-gynx treatment, and without grade ≥3 drug-related ocular, neuropathy, or alopecia events.3 The Phase 3 study (NCT07213804) evaluates LY4170156 as monotherapy in patients with PROC and in combination with bevacizumab in patients with platinum-sensitive ovarian cancer (PSOC)...In vivo efficacy studies showed that LY4170156 combined with cisplatin with or without bevacizumab, bevacizumab, doxorubicin, or carboplatin plus paclitaxel resulted in superior and more durable antitumor responses compared to SoC alone...Furthermore, LY4170156 plus olaparib demonstrated..."

ADC • Combination therapy • Preclinical • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Preclinical characterization of LY4336619, a novel ALPPL2xCD3 bispecific antibody, for the treatment of ovarian and endometrial cancer (AACR 2026) - "Additional preliminary studies revealed that the combination treatment with LY4170156, a clinical-stage anti-FRα antibody-drug conjugate (ADC), resulted in more sustained and pronounced tumor growth inhibition compared to either monotherapy alone. LY4336619 has the potential as a first-in-class medicine to treat ALPPL2-positive solid tumors, including ovarian and endometrial cancers. An IND submission is anticipated for 2026."

Bispecific • Preclinical • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALPG • ALPL • ALPP • FOLR1

Sofetabart mipitecan: Primary completion of P3 FRAmework-01 trial (NCT07213804) for ovarian neoplasm in Apr 2028 (Eli Lilly) - Q4 2025 Results: Completion of P3 FRAmework-01 trial for ovarian neoplasm in Aug 2031

Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer

Eli Lilly and Company...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. (PRNewswire) - "The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the Phase 1a/b study."

Breakthrough therapy • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

First patient enrolled in GOG-3133/ FRAmework-01 phase 3 study evaluating sofetabart mipitecan (LY4170156), a novel ADC targeting folate receptor alpha (FRα), in recurrent ovarian cancer (Eurekalert) - "This clinical trial has two parts; it tests a potential new medicine called sofetabart mipitecan for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based chemotherapy (platinum resistant). Part B looks at participants whose cancer has a higher chance of responding to platinum-based chemotherapy (platinum sensitive)."

Enrollment open • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

FRAmework-01: A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (clinicaltrials.gov) - P3 | N=1080 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

LOXO-FRA-24001: A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=495 | Recruiting | Sponsor: Eli Lilly and Company | N=360 ➔ 495

Enrollment change • First-in-human • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer

LY4170156: Primary completion of P1 trial (NCT06400472) for ovarian neoplasms in Feb 2027 (Eli Lilly) - Q3 2025 Results: Completion of P1 trial for ovarian neoplasms in Apr 2027

Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer