On March 15, 2025 AbbVie (NYSE: ABBV) reported the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy (Press release, AbbVie, MAR 15, 2025, View Source [SID1234651160]). At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice (IC) chemotherapy.1 Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE.2

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"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented today reinforce the importance of ELAHERE as a transformative therapy for patients with limited options," said Svetlana Kobina, MD, PhD, vice president, oncology medical affairs, AbbVie. "We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers."

In the United States, ovarian cancer is the leading cause of death from gynecological cancers.3 Each year, approximately 20,000 women are diagnosed.4 Unfortunately, most patients develop platinum-resistant disease, which is difficult to treat.5 In this setting, single-agent chemotherapies are associated with minimal survival benefit while adding significant toxicity burden.6

The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRα and had been treated with up to three prior therapies.1 Key findings from the 30.5-month median follow-up include:

ELAHERE treatment achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months, representing a 37% reduction in the risk of tumor progression or death (HR 0.63; [95% CI: 0.51, 0.79]) and a higher objective response rate of 41.9% versus 15.9%.
Superior and clinically meaningful overall survival for patients receiving ELAHERE (median 16.85 months) compared to IC chemotherapy (median 13.34 months), representing a 32% reduction in the risk of death (HR 0.68 [95% CI: 0.54, 0.84]).
Other endpoints included safety and duration of response (DOR), which were consistent with the primary data analysis at 13.1-months median follow-up.
The most common treatment-emergent adverse events (TEAEs) occurring in at least 20% of patients in the ELAHERE arm were blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea and peripheral neuropathy. Compared with IC chemotherapy, treatment with ELAHERE was overall associated with lower rates of grade ≥3 TEAEs, serious AEs and discontinuations due to AEs.

"The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy," said investigator and presenter, Toon Van Gorp, MD, PhD, Professor of Gynecologic Oncology, University of Leuven. "The significant improvements in survival, along with the well-characterized safety profile, reinforce ELAHERE as an emerging standard of care for difficult-to-treat ovarian cancer and warrants further study of this medicine in earlier treatment settings."

A separate analysis from the Phase 3 MIRASOL study evaluating the impact of [ELAHERE] treatment-emergent ocular events on patient-reported health-related quality of life (HRQoL), will be shared during an oral presentation March 17 at the SGO Annual Meeting scientific plenary session.

ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024. Marketing Authorization Applications for ELAHERE are also under review in multiple other countries.

About the Phase 3 MIRASOL Trial
MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator’s choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 RxDx Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). Sixty-two percent of patients received prior bevacizumab; 55% received a prior PARP inhibitor.

More information can be found on www.clinicaltrials.gov (NCT04209855).

About ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Patients requiring access support may call 1-833-ELAHERE or visit www.elahere.com.

ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION7
What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:

have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:
Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.

Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.
What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems.
have numbness or tingling in your hands or feet.
have liver problems.
are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Patients who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.

What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:

Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.
The most common side effects and abnormal labs of ELAHERE include:

• increased liver enzymes in the blood

• feeling tired

• blurred vision

• nausea

• diarrhea

• stomach-area (abdominal) pain

• changes in the cornea (part of the eye)

• peripheral neuropathy

• muscle, bone, or joint pain

• decreased red or white blood cell counts

• decreased platelets

• decreased magnesium level in the blood

• dry eye

• constipation

• vomiting

• decreased albumin level in the blood

• decreased appetite

Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.

These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

On March 15, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (Press release, Sutro Biopharma, MAR 15, 2025, View Source [SID1234651158]). The SGO Annual Meeting will take place from March 14-17, 2025 in Seattle, Washington.

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In this study, luvelta demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer across all levels of Folate Receptor-α (FRα) expression of 25% or greater, including an improved overall response rate (ORR), a low discontinuation rate, and a consistent safety profile across dose levels. Based on these findings, Sutro selected the optimized dose of luvelta: 5.2 mg/kg + G-CSF for two cycles then continued on 4.3 mg/kg.

"These data demonstrate the potential for improved patient responses compared to standard chemotherapy in PROC, especially patients whose FRα expression falls within the range of at least 25% to less than 75% 2+, which remains an important unmet medical need," commented Dr. Jung Yun Lee, Professor, Gynecologic Oncologist, Yonsei Cancer Center and Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

Late-Breaking Oral Presentation Highlights:

At the selected optimized dose (5.2 mg/kg), luvelta achieved an ORR of 32%1 and a disease control rate (DCR) of 96% compared to an ORR of 13.8% and a DCR of 69% for the 4.3 mg/kg group.
The demonstrated clinical activity in the 5.2 mg/kg group was consistent in patients across all levels of FRα expression of 25% or greater, with an ORR of 30.8% and a DCR of 100% for positive staining (PS) 2+ ≥75% (eligible for approved FRα-targeting ADC) and an ORR of 33.3%1 and DCR of 91.7%1 for PS2+ < 75%.
Safety was consistent across dosing groups, with no new safety signals observed and neutropenia well-managed.
The majority of patients across both dose cohorts received prior bevacizumab.
The presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com.

The Company recently announced that it is deprioritizing investment into the development of luvelta across all indications. Sutro continues to explore out-licensing opportunities to deliver the promise of luvelta’s benefit to patients with unmet need in platinum resistant ovarian cancer and beyond.

Immediately after data extraction, one additional patient experienced a confirmed PR and is included in the analysis.

About Luveltamab Tazevibulin

Luveltamab tazevibulin, abbreviated as "luvelta" and formerly known as STRO-002, is a FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. Developed and manufactured with Sutro’s cell-free XpressCF platform, luvelta is a homogeneous ADC with four hemiasterlin cytotoxins per antibody, precisely positioned to efficiently deliver to the tumor while ensuring systemic stability after dosing. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS2 Pediatric AML.

On March 14, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a third-party study published on March 6, 2025 in JAMA Oncology titled "Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Non-randomized Clinical Trial" provided data that support Multikine’s use as a neoadjuvant treatment in patients with tumors having low PD-L1 expression in its upcoming confirmatory head and neck cancer Registration Trial (Press release, Cel-Sci, MAR 14, 2025, View Source [SID1234651156]).

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"With these latest findings published in JAMA, industry is taking notice. We believe there is growing interest in Multikine as an advanced clinical stage asset that can prolong life for about 70% of head and neck cancer patients whose tumors have low PD-L1 expression," stated CEL-SCI’s CEO Geert Kersten.

The DEPEND study evaluated nivolumab as a neoadjuvant immunotherapy in human papilloma virus (HPV)–negative locoregionally advanced head and neck cancer. Nivolumab is already an FDA approved treatment for recurrent metastatic squamous cell carcinoma of the head and neck. The authors of the JAMA publication stated: "Taken together the DEPEND results further support the importance of PD-L1 expression as a predictive biomarker with immunotherapy trials in curative intent setting and may be an important selection criterion in subsequent trials".

The findings of the DEPEND study are very important and timely. They are similar to the findings in CEL-SCI’s Phase 3 study, namely that PD-L1 inhibitors such as Opdivo work best in patients who have high levels of PD-L1, but do not work well in patients with low or zero levels of PD-L1. Conversely, Multikine, which has a very different mechanism of action, worked best in patients who have low to zero levels of PD-L1. This underscores the potential of Multikine to address a critical unmet need amongst newly diagnosed head and neck cancer patients whose tumors have low PD-L1 expression, representing about 70% of this patient population.

The DEPEND Phase 2 data also confirm the independent findings reviewed by the FDA’s recent Oncologic Advisory Committee meeting (September 2024) on the use of checkpoint inhibitors including blockbuster drugs nivolumab and pembrolizumab, which appear to not work well in patients with low PD-L1 expression. To CEL-SCI’s knowledge, Multikine is the only oncology drug with solid data showing overall survival benefit when used as a neoadjuvant treatment in newly diagnosed locally advanced head and neck cancer patients whose tumors have low PD-L1 expression.

Multikine is an investigational cancer immunotherapy (treatment) given to newly diagnosed head and neck cancer patients before the primary standard of care treatment. CEL-SCI’s confirmatory Registration Trial, which has received the FDA’s go-ahead, will enroll patients with previously untreated resectable disease, stage 3 and 4 head and neck cancer who have low PD-L1 tumor expression and no lymph node involvement. During CEL-SCI’s completed Phase 3 clinical trial, the 5-year survival rate of this target patient population increased to 73% when patients were treated with Multikine before standard of care vs 45% for control patients who received only the standard of care treatments.

On March 14, 2025 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the publication of the study "Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study" in JU Open Plus this week (Press release, PhotoCure, MAR 14, 2025, View Source [SID1234651155]). The research objective was to assess if blue light cystoscopy (BLC) aided TURBT has an impact on the clinical outcomes of patients with NMIBC*. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort. These results are in line with prior results from multiple randomized controlled clinical trials.

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The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System.

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Outcomes data for BRAVO was measured at a 3-year time point in a predominately high-risk patient population. Median age at diagnosis was 71 years. Median follow-up was 3.7 years.

Study results include:

Risk of recurrence at 3-years was significantly reduced following BLC vs. WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of recurrence is in line with prior results from multiple randomized controlled clinical trials. A positive trend for reduction in risk of progression was also observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not statistically significant due to a low number of patients progressing on the study.
The study indicates that use of BLC can drive treatment decisions that lead to improved outcomes. Specifically highlighted in the study was that BLC patients were significantly more likely to receive intravesical BCG therapy (61% vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data supports reasoning that using BLC enhances a clinician’s ability to decide on the appropriate bladder cancer therapy based on precision risk stratification and a more complete TURBT.
The Veterans’ Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

"Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs. In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence. Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence", said Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, and one of the study authors.

"The exciting long-term real-world results from the BRAVO study complement and confirm the generalizability of prior recurrence outcomes with BLC beyond the randomized controlled trial setting, reflecting a routine clinical practice patient population", said Anders Neijber, Chief Medical Officer of Photocure.

Read the full publication here: View Source

An editorial to the publication can be found here: View Source

*NMIBC: Non muscle-invasive bladder cancer

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix/Cysview (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.
The following safety information is solely included to comply with U.S. regulatory requirements: Important Risk & Safety Information for Cysview (hexaminolevulinate HCl)

On March 14, 2025 iOncologi, Inc., a clinical-stage biopharmaceutical company focused on advancing immunotherapy platform technologies, reported the acquisition of TargImmune Therapeutics, a biotechnology company specializing in novel tumor targeted immunotherapies (Press release, iOncologi, MAR 14, 2025, View Source [SID1234651154]). This strategic acquisition significantly enhances iOncologi’s capabilities in developing cutting-edge immunotherapies for solid tumors.

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As part of the transaction, iOncologi, Inc. and TargImmune Therapeutics executed a share purchase agreement, resulting in iOncologi acquiring at least 99% of TargImmune’s shares, warrants, and options. Following the acquisition, TargImmune will continue to operate in Basel, Switzerland, as a wholly owned subsidiary of iOncologi, Inc. This structure ensures the seamless continuation of TargImmune’s research into novel tumor-targeted RNA therapies while benefiting from iOncologi’s expanded resources and strategic vision.

"This acquisition represents a pivotal moment for iOncologi as we continue to push the boundaries of immunotherapy for solid tumors," said Dr. Edgardo Rodriguez-Lebron, iOncologi’s recently appointed CEO. "TargImmune’s pioneering approaches perfectly align with our mission to develop transformative cancer therapies. By integrating two incredibly talented and highly experienced drug development teams, we are well-positioned to accelerate innovation and bring novel treatments to patients with limited therapeutic options."

The acquisition aligns with iOncologi’s broader strategy to expand its therapeutic pipeline, leverage next-generation RNA-based immunotherapies, and drive innovation in oncology.