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

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

Rinatabart sesutecan (Rina-S®) monotherapy in patients with advanced endometrial cancer: Part F of the phase 1/2 RAINFOL™-01 study [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • Monotherapy • P1/2 data • Endometrial Cancer • Oncology • Solid Tumor

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

Expanding ADC Therapy: rinatabart sesutecan in Ovarian and Endometrial Cancer (ESMO 2025) - "Sponsored by Genmab"

Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Genmab A/S…announced today updated data from cohort B2 of the Phase 1/2 RAINFOL-01 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC). (Businesswire) - "The study showed that at a median study follow-up of one year, treatment with Rina-S 100 mg/m² every 3 weeks (Q3W) resulted in a 50.0% confirmed objective response rate (ORR), including two complete responses (CR), in heavily pretreated patients with advanced endometrial cancer (EC) who had progressed following platinum-based chemotherapy and an immune checkpoint inhibitor. Additionally, at a median study follow-up of one year, 63.6% of responders (including CRs) in the 100 mg/m² cohort maintained their responses and remain on treatment."

P1/2 data • Endometrial Cancer

RINATABART SESUTECAN MONOTHERAPY IN PATIENTS WITH ADVANCED ENDOMETRIAL CANCER: PART F OF THE PHASE 1/2 RAINFOL™-01 STUDY (IGCS 2025) - P1/2 | "Current Status & Future Directions: The trial is currently enrolling. Study outcomes may provide further insights into whether Rina-S could be a safe and efficacious treatment for patients with EC."

Clinical • Metastases • Monotherapy • P1/2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor • FOLR1

PART C OF RAINFOL™-01: A PHASE 1/2 STUDY OF SINGLE-AGENT RINATABART SESUTECAN IN PATIENTS WITH ADVANCED AND/OR METASTATIC PLATINUM-RESISTANT OVARIAN CANCER (IGCS 2025) - P1/2 | "Prior therapies can include bevacizumab, PARP inhibitors, or mirvetuximab soravtansine (Table). Current Status & Future Directions: Part C is currently enrolling. Study outcomes may provide further insights on whether Rina-S could be a safe and efficacious treatment for patients with PROC."

Clinical • Metastases • P1/2 data • Platinum resistant • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • MUC16

A PHASE 3, OPEN-LABEL RANDOMIZED TRIAL TO COMPARE RINATABART SESUTECAN VERSUS INVESTIGATOR'S CHOICE OF CHEMOTHERAPY IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER: RAINFOL™-02 (ENGOT-OV86/GOG-3107) (IGCS 2025) - P1/2, P3 | "Patients will be randomized 1:1 to Rina-S 120 mg/m² IV Q3W or IC chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine). Current Status & Future Directions: The study is currently enrolling. Study outcomes may provide further insights into whether Rina-S could be a safe and efficacious treatment for patients with PROC."

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

Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S) in Advanced Endometrial Cancer (EC) (GlobeNewswire) - "Rina-S...will be further evaluated in a planned Phase 3 trial...The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL-01 trial (NCT05579366)....In the B2 cohort, 64 patients with heavily pretreated advanced or recurrent EC whose disease had progressed on or after an anti-PD-(L)1 and platinum-based chemotherapy were enrolled and treated with Rina-S."

Breakthrough therapy • New P3 trial • Endometrial Cancer

RAINFOL-03: Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer (clinicaltrials.gov) - P3 | N=544 | Not yet recruiting | Sponsor: Genmab

New P3 trial • Endometrial Cancer • Oncology • Solid Tumor

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

A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator's choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC). (ASCO 2025) - P1/2, P3 | "Pts will be randomized 1:1 to receive Rina-S 120 mg/m² IV Q3W or IC chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine). Follow-up visits will occur every 12 weeks for up to ~1 year after the treatment period. Key study criteria.MIRV, mirvetuximab soravtansine; PARP, poly-ADP ribose polymerase."

Clinical • P3 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1 • MUC16 • PARP1

Rina-S: Data readout from P3 RAINFOL-02 trial (NCT06619236) for platinum resistant ovarian cancer in 2026 (Genmab A/S) - ASCO 2025: Data from RAINFOL-03 trial for 2L endometrial cancer in 2027; Initiation of trial for 2L+ platinum sensitive ovarian cancer in H2 2025; Data from trial for 2L+ platinum sensitive ovarian cancer in 2028

Clinical data • New trial • P3 data • Platinum resistant • Platinum sensitive • Gynecologic Cancers • Oncology • Ovarian Cancer

Rina-S: “Rina-S Q3W showed encouraging single-agent antitumor activity not previously observed in patients with heavily-pretreated a/r EC after progression on platinum chemotherapy and a PD-(L)1“; Endometrial cancer (Genmab A/S) - ASCO 2025: "ORR of 50.0% (2 complete responses) with 100 mg/m2 and 47.1% with 120 mg/m2; At a median follow-up of 7.7 and 9.8 months, 73% and 63% of responses were ongoing with 100 mg/m2 and 120 mg/m2, respectively, suggesting durable responses"

P1/2 data • Endometrial Cancer • Gynecologic Cancers • Oncology

Rina-S: Initiation of P2 trial for 2L NSCLC in H2 2025 (Genmab A/S) - ASCO 2025: Data readout from P2 trial for 2L NSCLC in 2027

New P2 trial • P2 data • Non Small Cell Lung Cancer • Oncology

Genmab Announces Investigational Rinatabart Sesutecan (Rina-S) Demonstrates Encouraging Anti-Tumor Activity in Heavily Pretreated Patients with Advanced Endometrial Cancer in Phase 1/2 RAINFOL-01 Trial (Businesswire) - P1/2 | N=529 | RAINFOL-01 (NCT05579366) | Sponsor: Genmab | "Genmab...announced today new data from cohort B2 of the Phase 1/2 RAINFOL-01 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC). The study showed that with a median on-study follow-up of 7.7 months, treatment with Rina-S 100 mg/m2 every 3 weeks (Q3W) resulted in a 50.0 percent confirmed objective response rate (ORR), including two complete responses (CR), in heavily pre-treated advanced endometrial cancer (EC) patients who experienced disease progression on or after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor. The median duration of response (mDOR) was not reached...Anti-tumor activity was also observed in patients treated with Rina-S 120 mg/m2 Q3W, which resulted in 47.1 percent confirmed ORR....Serious TEAEs (Grade 3 or higher) occurred in 31.8 percent..."

P1/2 data • Endometrial Cancer

Rinatabart sesutecan (PRO1184) in combination with standard-of-care therapy exerted potentiated antitumor activity in preclinical cancer models (AACR 2025) - P1/2 | "Xenograft mouse models inoculated with OC (OVCAR-8 cells) or EC (HEC-1-A cells) received either phosphate-buffered saline (PBS) alone or Rina-S alone, with or without carboplatin (OC), bevacizumab (OC), or olaparib (EC). Syngeneic mouse models of lung cancer or colorectal cancer received either PBS alone or Rina-S alone, with or without an anti-PD1 agent nofazinilmab (CS1003)... These preclinical studies provide evidence for combination therapy with Rina-S and various SOC therapies and suggest that Rina-S may be investigated in different treatment settings in the clinic. A phase 1/2 study (NCT05579366) is currently ongoing to study the efficacy and safety of Rina-S in combination with carboplatin, bevacizumab, or pembrolizumab for the treatment of platinum-sensitive OC, PROC, and EC, respectively."

Combination therapy • IO biomarker • Preclinical • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CALR • FOLR1 • HMGB1

Rina-S: Launch for 2L+ platinum-resistant ovarian cancer (based on RAINFOL-02 trial) in 2027 (Genmab A/S) - ASCO 2025: Launch for 2L+ endometrial cancer (based on RAINFOL-03 trial) in 2028

Launch • Platinum resistant • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer

Genmab to Highlight New Data Evaluating Late-Stage Oncology Portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "The presentations will include the first disclosure of results from a Phase 1/2 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRa)-targeted, TOPO1-inhibor antibody-drug conjugate (ADC), in patients with recurrent/advanced endometrial cancer. Additionally, results from an analysis of the Phase 1/2 EPCORE NHL-1 study of epcoritamab, a T-cell–engaging bispecific antibody administered subcutaneously, including long-term follow-up in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who remain in complete response (CR) at 2 years, will be presented."

P1/2 data • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Non-Hodgkin’s Lymphoma

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

Rina-S: Initiation of P3 trial for 2L endometrial cancer by end of 2025 (Genmab A/S) - Q1 2025 Results

New P3 trial • Endometrial Cancer • Oncology

Rina-S: “Encouraging confirmed ORR, including deep responses, observed with Rina-S 120 mg/m2”; Ovarian cancer (Genmab A/S) - Q1 2025 Results

P1/2 data • Oncology • Ovarian Cancer

Genmab to Vigorously Defend Alleged Claims of Trade Secret Misappropriation by AbbVie Inc. (GlobeNewswire) - "Genmab A/S...announced today that AbbVie Inc...has filed a complaint in the U.S. District Court for the Western District of Washington (Seattle) naming Genmab A/S; ProfoundBio US Co.; ProfoundBio (Suzhou) Co., Ltd.; and former AbbVie employees as defendants. AbbVie alleges that the defendants have misappropriated AbbVie’s alleged trade secrets relating to the use of disaccharides to improve the hydrophilicity of drug-linkers in antibody-drug conjugates (ADCs) in connection with rinatabart sesutecan (Rina-S™) and other ADC pipeline products of ProfoundBio. Genmab acquired ProfoundBio in May 2024."

Corporate lawsuit • Oncology

Investigational Rinatabart Sesutecan (Rina-S) Continues to Show Encouraging Antitumor Activity in Patients with Advanced Ovarian Cancer (GlobeNewswire) - P1/2 | N=404 | RAINFOL-01 (NCT05579366) | Sponsor: Genmab | "Genmab A/S...announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S)...that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). The data are from the dose expansion cohort of the multi-part study evaluating the safety and efficacy of Rina-S as a single agent in solid tumors that are known to express FRα and were presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in Seattle, Washington."

P2 data • Ovarian Cancer

(ENCORE) Rinatabart Sesutecan (Rina-S) for Patients With Advanced Ovarian Cancer: Results From Dose Expansion Cohort B1 of a Phase 1/2 Study (SGO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Ovarian Cancer • Solid Tumor