Rina-S (rinatabart sesutecan) / Genmab - LARVOL DELTA

A phase I/II study of rinatabart sesutecan (Rina-S) in patients with advanced ovarian or endometrial cancer (ESMO 2024) - P1/2 | "FRα expression is retrospectively tested. As of 02 April 2024, 53 pts were treated in Part A. Of 32 pts with OC, median number of prior therapies was 5 (1–14); 75% had received bevacizumab; 91% were platinum resistant. Rina-S was well tolerated at 100 and 120 mg/m2, with manageable TRAEs. Promising antitumor activity was observed across a wide range of FRα expression levels. Enrollment for Part B OC pts is complete; dose optimization analysis will be presented."

Clinical • IO biomarker • Metastases • P1/2 data • Endometrial Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Rinatabart sesutecan (Rina-S) for patients with advanced endometrial cancer: First disclosure from dose expansion cohort B2 of the GTC1184-01 study. (ASCO 2025) - P1/2 | "Rina-S showed encouraging anti-tumor activity in pts with heavily pretreated EC and had a manageable safety profile consistent with previous reports. Further evaluation of single-agent Rina-S in pts with advanced EC is ongoing."

Clinical • Metastases • Anemia • Endometrial Cancer • Interstitial Lung Disease • Neutropenia • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • FOLR1 • PD-L1

Rinatabart sesutecan (Rina-S®) for patients with advanced or recurrent endometrial cancer (a/r EC): Update from dose expansion cohort B2 of RAINFOL™-01 (ESMO 2025) - P1/2 | "Conclusions In patients with heavily pretreated a/r EC post ICI-chemo, Rina-S 100 mg/m 2 had encouraging antitumor activity, with response rates not previously observed in this setting, and manageable toxicity. Further investigation is ongoing in Part F of RAINFOL-01."

Clinical • IO biomarker • Metastases • Endometrial Cancer • Oncology • Solid Tumor • FOLR1

RAINFOL-02: An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (clinicaltrials.gov) - P3 | N=82 | Recruiting | Sponsor: Genmab | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Rina-S: Data readout from P3 RAINFOL-02 trial (NCT06619236) for 2L+ platinum resistant ovarian cancer in Q4 2026 (Genmab A/S) - Q2 2026 Results

P3 data • Platinum resistant • Gynecologic Cancers • Oncology • Ovarian Cancer

MODULE 2: Strategies Targeting Folate Receptor Alpha (FRα) in Advanced OC (ASCO 2026) - "Supported by This activity is supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, and Merck. Incidence and clinical relevance of FRα expression in OC; optimal approaches to and timing of FRα testingLong-term data, including OS findings, with mirvetuximab soravtansine for patients with FRα-positive, platinum-resistant OC from the Phase III MIRASOL trial; optimal integration into current management algorithmsKey findings from the Phase II PICCOLO trial of mirvetuximab soravtansine for FRα-positive, platinum-sensitive OC; current and potential clinical roleDesign, eligibility criteria and primary and secondary endpoints of the Phase III GLORIOSA trial evaluating mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive OC who have not experienced disease progression after second-line platinum-based chemotherapy and bevacizumabMechanistic..."

Metastases • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

RAINFOL-07: Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer (clinicaltrials.gov) - P3 | N=688 | Recruiting | Sponsor: Genmab | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD

ENCORE: Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov) - P1/2 | N=529 | Recruiting | Sponsor: Genmab | N=404 ➔ 529 | Trial completion date: Oct 2026 ➔ Sep 2027 | Trial primary completion date: Apr 2026 ➔ Jun 2027

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer • FOLR1 • HER-2

PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=374 | Recruiting | Sponsor: ProfoundBio US Co. | N=134 ➔ 374 | Trial completion date: Sep 2025 ➔ Apr 2026 | Trial primary completion date: Jan 2025 ➔ Oct 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

RAINFOL-01: Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov) - P1/2 | N=764 | Recruiting | Sponsor: Genmab | N=569 ➔ 764

Enrollment change • Platinum resistant • Platinum sensitive • Breast Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Uterine Cancer • FOLR1 • HER-2

Rinatabart Sesutecan (Rina-S) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001) (clinicaltrials.gov) - P1/2 | N=404 | Recruiting | Sponsor: Genmab | Trial completion date: Apr 2026 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

RAINFOL-02: Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=530 | Active, not recruiting | Sponsor: Genmab | Recruiting ➔ Active, not recruiting

Enrollment closed • Platinum resistant • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1

RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Genmab | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=530 | Recruiting | Sponsor: Genmab | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Solid Tumor

PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=134 | Not yet recruiting | Sponsor: ProfoundBio US Co.

New P1/2 trial • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

PRO1184-001: PRO1184 for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: ProfoundBio US Co. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=530 | Not yet recruiting | Sponsor: Genmab

New P3 trial • Oncology • Ovarian Cancer • Solid Tumor

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=530 | Not yet recruiting | Sponsor: Genmab | Trial completion date: Nov 2029 ➔ Apr 2028 | Trial primary completion date: Feb 2027 ➔ May 2027

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

RAINFOL-02: Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P3 | N=530 | Recruiting | Sponsor: Genmab | Trial primary completion date: May 2027 ➔ Feb 2027

Platinum resistant • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Genmab

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Genmab

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RAINFOL-05: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Genmab | N=107 ➔ 240

Enrollment change • Trial initiation date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer. (ASCO 2026) - P1/2, P3 | "Standard treatment for recurrent PSOC includes platinum-based chemotherapy ± bevacizumab (BEV), but in most patients, disease progression occurs within a year. Additional secondary endpoints include PFS per RECIST v1.1 by blinded independent central review, PFS2 (time from randomization to the second progression or death), safety, and patient-reported outcomes. The trial is currently recruiting."

Clinical • P3 data • Platinum sensitive • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

RAINFOL-03 (ENGOT-EN-31/GOG-3128): A global, phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator's choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death-ligand 1 inhibition. (ASCO 2026) - P1/2, P3 | "Patients will be randomized 1:1 to receive Rina-S 100 mg/m2 intravenously every 3 weeks or IC therapy (paclitaxel or doxorubicin) until disease progression or unacceptable toxicity. Additional secondary endpoints include PFS and ORR per RECIST v1.1 by blinded independent central review (BICR), duration of objective response per RECIST v1.1 by investigator assessment and BICR, safety, and quality of life outcomes. The trial is currently recruiting."

Clinical • P3 data • Carcinosarcoma • Endometrial Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Sarcoma • Solid Tumor • FOLR1 • PD-L1

RAINFOL-02: An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (clinicaltrials.gov) - P3 | N=82 | Not yet recruiting | Sponsor: Genmab

New P3 trial • Platinum resistant • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA