Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment in Participants With Ovarian Cancer Following First-Line (1L) Platinum-Based Chemotherapy

This Phase 3 study will be conducted in different countries around the world with up to approximately 602 participants.
The purpose of this study is to evaluate how well Rina-S alone or in combination with an approved, standard of care (SOC) treatment works against ovarian cancer (including primary peritoneal or fallopian tube cancer) compared to the same available SOC therapy by itself, or no treatment (only monitoring).
On average, the expected trial duration for an individual participant will be approximately 4 years (depending on treatment received). The treatment length and follow-up duration will be different for every participant, but an average of 16 months of treatment is expected, followed by an estimated 29-month post treatment follow up period.
Participation in the study will require visits to the study site(s). Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the trial treatment is safe and effective. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep receiving trial treatment for the protocol-defined study duration.

Start Date01 Nov 2026

Sponsor / Collaborator

Genmab A/S

NCT07564141

/ RecruitingPhase 3

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.
Participants will receive either:
* Rina-S monotherapy (by itself),
* Rina-S plus bevacizumab,
* investigator's choice chemotherapy (by itself) (standard of care), or
* investigator's choice chemotherapy plus bevacizumab (standard of care).
No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Start Date28 Aug 2026

Sponsor / Collaborator

Genmab A/S

NCT07539311

/ RecruitingPhase 2

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.
The purpose of this study is to evaluate how well Rina-S works against GI cancers.
The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.
Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Start Date11 May 2026

Sponsor / Collaborator

Genmab A/S

100 Clinical Results associated with Rinatabart Sesutecan

100 Translational Medicine associated with Rinatabart Sesutecan

100 Patents (Medical) associated with Rinatabart Sesutecan

News (Medical) associated with Rinatabart Sesutecan

20 Oct 2026

·www.biospace.com

Epkinly data only one of Genmab’s make-or-break readouts ahead of steep sales erosion

iStock, z_wei Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession. Genmab faces an unprecedented situation. Nearing the loss of a revenue source that accounts for 90% of its sales, the company is approaching arguably the largest cliff that any company has ever faced in the pharma industry, Tahamtan Ahmadi, chief medical officer and head of experimental medicines at Genmab, told BioSpace . And a series of readouts this quarter could foreshadow whether the company will grow beyond the cliff. Two clinical wins earlier this month have set the stage with two more readouts still expected by the end of the year. Today, Genmab relies heavily on royalties from Darzalex, its Johnson & Johnson–partnered cancer drug whose U.S. patents expire in 2029. Genmab lost cases that could have softened the drop in revenues as these patents run out, creating a steep cliff. The biotech’s Darzalex revenues could fall from about $3.3 billion in 2028 to under $1 billion by 2031, and to roughly zero by 2032, Raghuram Selvaraju, managing director of Healthcare Equity Research at H.C. Wainwright, told BioSpace by email. Despite that, the analyst believes Genmab can emerge from the trough years of 2029 and 2030 in a strong position. “We think Genmab has more than enough horsepower under the hood to overcome the almost total loss of revenue from Darzalex,” Selvaraju said. “Genmab’s ability to weather this challenge depends on three wholly owned or partnered oncology assets.” The company recently shared positive data on two of the three assets. In the first week of October, Genmab reported Phase 3 findings from the AbbVie-partnered Epkinly in first-line lymphoma that analysts said could potentially set “the new standard of care” in this indication and posted “durable and clinically meaningful” Phase 2 results for the antibody-drug conjugate (ADC) rinatabart sesutecan (Rina-S) in ovarian cancer. Genmab expects Phase 3 Rina-S data this year, but Selvaraju now sees data on the third asset, petosemtamab, as the only “binary event risk.” Lymphoma AbbVie, Genmab’s Epkinly sets ‘new standard of care’ in first-line lymphoma in Phase 3 AbbVie and Genmab’s bispecific antibody blew analyst expectations out of the water with a 51% improvement in progression-free survival when used alongside a standard frontline regimen in diffuse large B cell lymphoma—potentially setting up a battle with Roche’s Polivy. October 6, 2026 · 3 min read · Tristan Manalac Read more Genmab’s big bet Genmab acquired petosemtamab, a bispecific antibody targeting EGFR and LGR5, last year in its $8 billion takeover of Merus. Among Genmab’s three key assets, “petosemtamab matters the most,” Selvaraju said. That view reflects a sales ramp that could make the bispecific a blockbuster by 2029, the year Darzalex’s U.S. patents expire, as well as possible launches in additional indications. The lead indication for petosemtamab is head and neck squamous cell carcinoma (HNSCC). Genmab expects to share results from the Phase 3 LiGeR-HN1 trial in patients with first-line HNSCC by the end of the year. In May 2025, Merus reported a 63% overall response rate (ORR) in a Phase 2 study, far surpassing the 19% Merck’s Keytruda achieved in the Phase 3 KEYNOTE-048 study—a result noted by both Selvaraju and Genmab’s Ahmadi. Achieving a 40-point or greater improvement in ORR, a co-primary endpoint in the Phase 3 trial, “would support accelerated approval and fast uptake,” Selvaraju said. Beyond that, Genmab would need to show that the increased response rate translates into improved progression-free (PFS) and overall survival (OS), the latter the study’s other primary outcome measure. PFS is a secondary endpoint. Ahmadi outlined how ORR could predict PFS and OS. “If you have a dramatic ORR difference, and the durability is good, it almost has to translate into a statistical or near-statistical PFS difference. And then, of course, it has to translate into separation in the OS curves, because otherwise it would have a safety liability,” the CMO said. Business Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more New data for Genmab and AbbVie’s bispecific antibody Epkinly wowed analysts and could set the partners up for an expanded approval in diffuse large B cell lymphoma; deals have flowed steadily this week, including Novartis’ nearly $8 billion bet on mRNA drugs with China’s Abogen Biosciences; and could Sarepta Therapeutics turn things around from last year’s annus horribilis? October 7, 2026 · 2 min read · Jef Akst Read more ADC nears key readout LiGeR-HN1 is one of two remaining Phase 3 readouts for Genmab assets this year. The biotech also plans to share data from RAINFOL-02 , which is testing its FRα-directed ADC Rina-S in platinum-resistant ovarian cancer (PROC). The readout is “relatively risk-mitigated because of the positive Phase 1/2 RAINFOL-01 data in PROC,” Selvaraju said. The Phase 1/2 clinical trial linked Rina-S to a median PFS of 9.5 months, hitting a secondary endpoint. AbbVie’s rival FRα-directed ADC Elahere achieved a median PFS of 5.6 months in the Phase 3 MIRASOL trial. Chemotherapy is the control treatment in RAINFOL-02. Based on the earlier data on Rina-S and chemotherapy, the RAINFOL-02 readout could be “very positive on PFS and potentially even on OS,” Ahmadi said. A positive PFS outcome—the trial’s primary endpoint—is “highly likely, with interim OS success (a higher bar) being possible in an upside scenario,” Guggenheim Securities analysts said in an Oct. 4 note to investors. Analysts are also looking for Genmab to replicate the breadth of efficacy seen in the Phase 1/2 trial, when the biotech reported activity in patients with low or no FRα expression. Securing a label across FRα levels would double the addressable population compared to Elahere, Selvaraju said. The analyst sees the FRα labeling terms as the variable that will determine the slope of the ramp for Rina-S sales. The competitive landscape amplifies the value of launching and growing Rina-S quickly. Rina-S is part of a wave of ADCs that use topoisomerase-1 (TOPO-1) inhibitors to treat ovarian cancer. Once a patient progresses after receiving one TOPO-1 ADC, they are unlikely to benefit from another treatment with the same payload, Ahmadi said. The importance of becoming the first-choice TOPO-1 ADC is encouraging speed and secrecy. “We are not pre-announcing these studies anymore. We basically make them public at the time the first patient gets dosed,” Ahmadi said. “It is competitive and everybody’s looking over everybody’s shoulder and copying everybody’s strategy.” Competing commercially Victories in LiGeR-HN1 and RAINFOL-02 would establish petosemtamab and Rina-S alongside Epkinly as drugs that can power Genmab through and beyond the Darzalex cliff. Yet positive data will only be a step toward the sales Genmab needs to mitigate the loss of royalties from the drug. Genmab also needs to achieve regulatory and commercial successes, and it is facing those challenges solo. The market “is still a little bit skeptical” about Genmab’s prospects in this respect, Ahmadi acknowledged. Genmab is entering “a hypercompetitive environment” and biotechs always face questions about whether they can compete commercially with larger rivals, he added. Ahmadi sees Epkinly’s success as evidence that Genmab can rise to the challenge. Working with AbbVie, Genmab has turned Epkinly into a challenger to Roche, a company that “owned” the market for 25 years with Polivy and Rituxan, Ahmadi said. Through that process, Genmab has built commercial and operational capabilities that could benefit petosemtamab and Rina-S. “We’ve been beating [Roche’s Columvi] quarter for quarter for quarter,” Ahmadi said. “I think that is a little bit unappreciated: how good we have become in running these trials, speeding up development, and how competitive we already are as a company.”

Clinical ResultPhase 3AcquisitionADC

05 Oct 2026

·www.fiercebiotech.com

Genmab ph. 2 data spur claim ADC ‘clearly superior’ to Elahere

Genmab has linked an antibody-drug conjugate (ADC) to a median progression-free survival (PFS) of 9.5 months, leading TD Cowen analysts to hail the asset as “clearly superior” to AbbVie’s Elahere. Like Elahere, Genmab’s rinatabart sesutecan (Rina-S) is an FRα-directed ADC. Part C of Genmab’s phase 1/2 Rainfol-01 trial tested Rina-S in 109 patients with platinum-resistant ovarian cancer (PROC). Genmab reported an objective response rate (ORR) of 55.6% in ovarian cancer patients in an earlier part of the trial. ORR was lower in part C, clocking in at 45.9%. Yet, while noting that ORR “moderated” in the new data, TD Cowen analysts hailed the readout as a boost for Genmab in a note to investors titled “Rina-S Makes It RAIN.” Rina-S “ought to overtake” Elahere given its differentiated efficacy and safety and is ahead of the pack of next-generation FRα-directed ADCs, the analysts argued. Calling the efficacy results “solid,” the analysts focused on cross-trial survival comparisons. Median PFS of 9.5 months for Rina-S is “meaningfully better than Elahere’s 5.6 months,” they said, quoting data from a phase 3 trial that compared AbbVie’s ADC to chemotherapy in 453 patients. The Rina-S result “establishes strong durability in a broad, heavily pre-treated population,” the analysts continued. In Genmab’s study, 53% of patients had received three or four prior lines of therapy. All patients had received prior bevacizumab and taxane therapy. Almost half of the patients had tried a PARP inhibitor, and one-third had received Elahere. Genmab reported antitumor activity regardless of prior treatment with Elahere. Similarly, Genmab saw activity in patients with low FRα expression and non-expressors. Elahere is indicated for FRα-positive PROC. The data were positive when it came to adverse events. Elahere has (PDF) a boxed warning for ocular toxicity, and AbbVie's drug has been associated with Grade 3 ocular adverse reactions in 11% of patients. In contrast, Genmab's latest data revealed no safety signals for ocular toxicity or peripheral neuropathy, interstitial lung disease or stomatitis. AbbVie has reported grade 4 cases of keratopathy and cataract, while fatigue, nausea and vomiting were more common on Rina-S than Elahere. TD Cowen analysts said Genmab’s data provide a “clear read-through” for the phase 3 Rainfol-02 trial, which is comparing Rina-S to the investigator’s choice of treatment in PROC. The primary endpoint of that study is PFS and Genmab expects (PDF) to share some data this year. The biopharma predicts that the trial, plus studies in endometrial cancer and in platinum-sensitive ovarian cancer (PSOC), can drive Rina-S sales north of $2 billion. Elahere, which is not used in endometrial cancer or PSOC, generated $690 million in 2025, its third full year on the market. Part C data “reinforce our confidence that Rina-S will outpace this trajectory as the clearly superior drug,” the analysts said. AbbVie is defending its business in the courts. Last year, AbbVie accused Genmab of being “willfully blind” to the theft of trade secrets when buying Rina-S in its $1.8 billion ProfoundBio takeover . Genmab provided (PDF) an update on the allegations, which it refutes, in its second-quarter earnings. Assessing the most active areas of Big Pharma deal-making is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

Clinical ResultPhase 3ADC

05 Oct 2026

·www.biospace.com

Genmab Announces Rinatabart Sesutecan (Rina-S®) Phase 2 RAINFOL™-01 Results Demonstrated Durable and Clinically Meaningful Responses in Patients with Platinum-Resistant Ovarian Cancer

Media Release COPENHAGEN, Denmark; October 3, 2026 Treatment with Rina-S ® 120 mg/m² every three weeks demonstrated a clinically meaningful objective response rate (ORR) and durable median duration of response (mDOR) in patients with platinum-resistant ovarian cancer (PROC) Antitumor activity was observed regardless of folate receptor alpha (FRα) expression levels, including low FRα expression and non-expressors Genmab A/S (Nasdaq: GMAB) today announced results from Part C of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC) , demonstrated that among 109 treated patients with platinum-resistant ovarian cancer (PROC), Rina-S achieved a confirmed objective response rate (ORR) of 45.9% (95% CI: 36.3–55.7), including five complete responses (CRs) and a median duration of response (mDOR) of 12.1 months (95% CI: 6.5–15.4), with 51% of responders remaining in response at one year. The findings were presented today in a Late-Breaking Oral Session at the International Gynecologic Cancer Society (IGCS) Congress 2026, held in Montreal, Canada. The study also demonstrated a median progression-free survival (mPFS) of 9.5 months (95% CI: 7.6–11.3). Antitumor activity was observed regardless of FRα expression levels, including in patients with low FRα expression and non-expressors, and regardless of prior treatment with mirvetuximab. “Platinum-resistant ovarian cancer is a difficult-to-treat disease. As patients relapse and progress through successive lines of therapy, achieving durable clinical benefit becomes increasingly challenging, yet remains critically important,” said Elizabeth K. Lee, M.D., study investigator and a medical oncologist in the gynecologic oncology program at Dana-Farber Cancer Institute. “The antitumor activity and durability observed with Rina-S in this heavily pretreated population are encouraging and suggest the potential to meaningfully impact outcomes for patients facing a particularly challenging stage of disease.” The Part C cohort of the Phase 1/2 RAINFOL-01 study evaluated Rina-S 120 mg/m² Q3W as monotherapy in patients with platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. Eligible patients received one to three prior lines of therapy; patients who received mirvetuximab as their last prior therapy could have received up to four prior lines. More than half of patients (53%) had received three or four prior lines of therapy. All patients had received prior bevacizumab and taxane therapy; 49.5% had received a prior PARP inhibitor, and 33% had received prior mirvetuximab soravtansine. Median follow-up exceeded one year. The most common treatment-emergent adverse events (TEAEs) included fatigue (57.8%) and low-grade (Grade 1-2) gastrointestinal events, such as nausea (67.9%), vomiting (36.7%), constipation (26.6%), decreased appetite (23.9%), and abdominal pain (18.3%). The most frequently reported hematologic TEAEs included anemia (57.8%), neutropenia (57.8%), decreased platelet count (34.9%), and thrombocytopenia (34.9%). Serious adverse events (SAEs) were reported in approximately one-third of participants. Treatment discontinuation due to TEAEs occurred in 5.5% of participants. No safety signals for ocular toxicity, peripheral neuropathy, interstitial lung disease (ILD), or stomatitis were observed. “The late-breaking results presented today add an important layer of evidence to the growing clinical experience with Rina-S in patients with platinum-resistant ovarian cancer,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “These findings, including the observed antitumor activity, duration of response, and the first progression-free survival data reported for the program, as well as the manageable tolerability, reinforce the potential of Rina-S. As our Phase 3 program continues to advance, the results further inform our evaluation of Rina-S as a potential treatment option for patients with gynecologic cancers.” Rina-S is being evaluated in a broad clinical development program spanning multiple gynecologic cancers and other solid tumors. The program includes four Phase 3 trials evaluating Rina-S in PROC (RAINFOL-02; NCT06619236 ), recurrent or progressive endometrial cancer (RAINFOL-03; NCT07166094 ), platinum-sensitive ovarian cancer (PSOC) maintenance therapy (RAINFOL-04; NCT07225270 ), and second-line PSOC (RAINFOL-07; NCT07564141 ). Additional studies include the Phase 1/2 RAINFOL-01 trial ( NCT05579366 ) and Phase 2 trials in non-small cell lung cancer (RAINFOL-05; NCT07288177 ) and advanced gastrointestinal cancers (RAINFOL-09; NCT07539311 ). About the RAINFOL-01 Trial RAINFOL-01 ( NCT05579366 ) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in selected solid tumors, including tumors across a range of FRα expression levels. The study consists of multiple parts, including the PROC monotherapy cohort. About Ovarian Cancer Ovarian cancer (OC) is a major global health issue, with more than 320,000 new cases diagnosed annually worldwide. i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally. ii The disease is often diagnosed at an advanced stage because its symptoms, including abdominal bloating, pelvic pain, and difficulty eating, can be subtle and nonspecific. iii Approximately 70-90% of women with advanced-stage OC worldwide experience a recurrence after initial treatment. iv OC has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%. v , vi About Rinatabart Sesutecan (Rina-S; GEN1184) Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial, and other cancers with unmet need. The safety and efficacy of Rina-S have not been established. Please visit for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn , X , Facebook and Instagram . Contact: David Freundel, Senior Director, Global Communications & Corporate Affairs T: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo ® ; HuMax ® ; DuoBody ® ; HexaBody ® ; DuoHexaBody ® , HexElect ® , KYSO ® and RAINFOL™; Rina-S ® is a trademark of ProfoundBio, US, Co. and Genmab (Suzhou) Co., Ltd. i World Cancer Research Fund International. . Accessed Oct 2025. ii World Ovarian Cancer Coalition. . Accessed Oct 2025. iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002. iv Ovarian Cancer Research Alliance. v European Institute of Women's Health. ‐brief‐women‐and‐ovarian‐cancer‐in‐the‐eu‐2018/ . Accessed Oct 2025. vi American Cancer Society. Stages of Ovarian Cancer. . Accessed Oct 2025. Media Release no. 12 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 100326_MR12_Rina-S_IGCS2026

Clinical ResultPhase 2Phase 3Phase 1ADC

100 Deals associated with Rinatabart Sesutecan

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 3	-	Genmab A/S	01 Nov 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	United States	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Japan	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Belgium	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Finland	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	France	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Norway	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Poland	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Spain	Genmab A/S	03 Apr 2026
Recurrent Endometrial Cancer	Phase 3	United States	Genmab A/S	28 Nov 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05579366 (RAINFOL-01, IGCS2026)	Phase 2	Platinum-Resistant Ovarian Carcinoma	109	Rina-S 120 mg/m2 Q3W	iwdqjrexbn(pobgsanltc) = fidntnsqrk qwvfwjtztt (rftwcnmjql, 36.3 - 55.7) View more	Positive	01 Oct 2026
NCT07166094 (RAINFOL-03, ASCO2026)	Phase 3	Endometrial Carcinoma folate receptor alpha (FRα)	544	Rina-S 100 mg/m2	tagcjxmjiv(kfmcacnmbx) = jtngnrvvoj zvhiznewtt (nbxwtmfeip, 22 - 35) View more	Positive	29 May 2026
				Investigator’s choice (IC) therapy (paclitaxel or doxorubicin)	toqvtjkdyq(frpzpmlyab) = gnjpgauoix bvlykcqros (spvkobxdkg ) View more
NCT05579366 (SGO2025)	Phase 1/2	Ovarian Cancer	42	Rinatabart sesutecan 100 mg/m2	aloaxsdcyi(ekuevewvnn) = Treatment with Rina-S was well tolerated, with manageable TEAEs. tgjpashpmn (ojcdlvwjkb )	Positive	01 Sep 2025
				Rinatabart sesutecan 120 mg/m2
NCT05579366 (SGO2025)	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	100	Rinatabart sesutecan 120 mg/m2 IV Q3W	yfvxbeclko(iecopcjewp) = zbksljuaof impnboldtn (qvryeipxyy )	Positive	01 Sep 2025
NCT05579366 (RAINFOL-01, GlobeNewswire \| NEWS) Manual	Phase 1/2	Advanced Endometrial Carcinoma	64	Rina-S 100 mg/m^2Rina-S 100 mg/m^2	cqgaxfbjdi(trcxurkmjb) = rokxefoxbx jsvecpqvrq (fddqdhcwbo, 28.2 - 71.8) View more	Positive	02 Jun 2025
				Rina-SRina-S 120 mg/m^2	cqgaxfbjdi(trcxurkmjb) = ooukyejrvp jsvecpqvrq (fddqdhcwbo, 29.8 - 64.9) View more
NCT05579366 (GCT1184-01, ASCO2025) Manual	Phase 1/2	Advanced Endometrial Carcinoma	64	Rina-S 100 mg/m2Rina-S 100 mg/m2	kwtmjvgfod(tkzoajiqlg) = zpxdtshjur gyjzdvjefm (ycorkjkdrn ) View more	Positive	30 May 2025
				Rina-SRina-S 120 mg/m2	kwtmjvgfod(tkzoajiqlg) = ciehthlsgk gyjzdvjefm (ycorkjkdrn ) View more
NCT06619236 (phase 3 study, ASCO2025)	Phase 3	Platinum-Resistant Ovarian Carcinoma folate receptor alpha (FRα)	-	Rinatabart sesutecan (Rina-S) 120 mg/m² IV Q3W	wmkvyhkmga(nbltxasxyn) = zxotovkabv wtnpwrvenm (ffwbxkbbaa, 26 - 74)	Positive	30 May 2025
NCT05579366 (RAINFOL-01, PipelineReview) Manual	Phase 1/2	Ovarian Cancer	40	Rina-S 120 mg/m^2	cffmfwfoci(tzyswokbwk) = egcvtkdnjx rxclsubdsb (jirdahsfqj, 30.8 - 78.5) View more	Positive	17 Mar 2025
				Rina-S 100 mg/m^2	cffmfwfoci(tzyswokbwk) = pebabkhqrz rxclsubdsb (jirdahsfqj, 7.8 - 45.4) View more
NCT05579366 (NEWS) Manual	Phase 1/2	Primary peritoneal carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma	42	Rina-S 100 mg/m2	cqygefhvnl(wftojutwyb) = hrosbeevub olbnenpngb (uquqlpelov ) View more	Positive	23 Sep 2024
				Rina-S 120 mg/m2	cqygefhvnl(wftojutwyb) = rshugmrnen olbnenpngb (uquqlpelov ) View more
NCT05579366 (PRO1184-001, ESMO2024) Manual	Phase 1/2	Ovarian Cancer \| Endometrial Carcinoma Second line \| Last line \| Third line Folate receptor alpha Positive	101	Rina-S 100 mg/m2	brtddppfup(fukcbzlvuf) = For Part A pts treated at 100 or 120 mg/m2 (n=35), the most common (≥20%) treatment-related adverse events (TRAEs) were nausea (n=20, 57%), neutropenia (n=18, 51%), leukopenia (n=16, 46%), anemia (n=15, 43%), thrombocytopenia (n=11, 31%), and vomiting (n=9, 26%); most events were Grade 1/2. The most common (≥10%) ≥ Grade 3 TRAEs were neutropenia (n=12, 34%), anemia (n=9, 26%), leukopenia (n=8, 23%), and thrombocytopenia (n=5, 14%). No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. lgzxdekfty (kydpiralph )	Positive	15 Sep 2024
				Rina-S 120 mg/m2

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis