On September 9, 2024 Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), reported positive results from its QUILT 3.055 trial demonstrating long-term extended survival of 14 months to as much as five years for patients with advanced non-small cell lung cancer (NSCLC) being treated with checkpoint inhibitors (CPI) (Press release, ImmunityBio, SEP 9, 2024, View Source [SID1234646433]). An oral presentation of the data was presented by John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, at the World Congress on Lung Cancer in San Diego on Sunday, September 8 in the session titled "Novel Immunotherapy Strategies and Combinations."

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The phase 2b study of ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with checkpoint inhibitors KEYTRUDA or OPDIVO in multiple tumor types including NSCLC who failed CPI showed long-term overall survival of 57 percent (49/86) and 34 percent (29/86) at 12 and 18 months respectively, exceeding the current standard of care.

"Most NSCLC patients experience progression following checkpoint inhibitors, with average survival well under a year when checkpoint inhibitor-based therapies fail our patients," said Dr. Wrangle. "The QUILT-3.055 study enrolled patients relapsed after CPI and CPI in combination with chemotherapy and showed that, regardless of prior therapy, adding the IL-15-based superagonist ANKTIVA to their therapy could rescue checkpoint activity likely through activation of NK cells, CD4+, CD8+, and memory T cells. The survival rate in these patients on their 2nd or 3rd line of cancer therapy is impressive and exceeds what you might expect from the current standard of care."

About the QUILT-3.055 Study

Non-small cell lung cancer occurs when malignant cells form in the lung’s tissue and it accounts for approximately 85% of all lung cancer cases. Lung cancer is by far the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths, according to the American Cancer Society.

The QUILT-3.055 study examined overall survival in 86 patients with 2nd and 3rd line+ NSCLC who were previously treated and failed either CPI alone or failed CPI in combination with chemotherapy. These patients had received no intervening therapy. Patients received ANKTIVA 15 mcg/kg subcutaneously every 3 weeks in combination with the same checkpoint inhibitor they previously received and on which they had progressed.

The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with survival ranging up to 58 months. Overall survival for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 16.2) versus PDL1-ve (N=33) of 15.8 months (95% CI 11.5, 24.0). The ANKTIVA adverse event profile was consistent with CPI alone with no cytokine release syndrome observed. Only 10% of participants had any grade ≥3 ANKTIVA-related adverse events. The study demonstrates long-term survival at ≥12 and ≥18 months of 49/86 (57%) and 29/86 (34%) patients respectively.

ANKTIVA plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of ANKTIVA to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median overall survival of 57% and 34% at 12 and 18 months, respectively, exceeding the standard of care.

Based on the results of the QUILT 3.055 study and other trials involving ANKTIVA with checkpoint inhibitors, ImmunityBio is opening Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC.

"The clinical trial protocol was designed such that the duration of experimental therapy with ANKTIVA plus CPI was 24 months, and thereafter no further ANKTIVA doses were administered. Despite this, the results demonstrated that 27% of the participants survived beyond the 2-year therapy period, indicating the potential benefit of ANKTIVA to activate memory T cells and prolonged therapeutic benefit after study treatment was completed," said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. "Based on this study, the ResQ studies have been activated as randomized Phase 3 trials in both 1st. and 2nd line NSCLC by combining ANKTIVA with pembrolizumab or nivolumab versus standard of care. The current results presented at World Congress on Lung Cancer confirm that by activating the body’s natural immune system and proliferating natural killer cells, killer T cells, and memory T cells, this IL-15 superagonist boosts, or rescues, the checkpoint inhibitor likely by reactivating MHC1 expression on the tumor. We are excited at the potential of converting a MHC-ve cold tumor to a MHC+ve hot tumor and evolving the field of immunotherapy beyond T cells."

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com. You are encouraged to report negative side effects of prescription drugs to FDA.

Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)

On September 9, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of PT886 in combination with chemotherapy (Press release, Phanes Therapeutics, SEP 9, 2024, View Source [SID1234646449]). Dosing has been completed in two cohorts: one for first-line treatment of pancreatic cancers and another for second-line treatment of gastric, gastroesophageal junction cancers.

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PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study PT886 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655).

On September 9, 2024 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported that management will participate in the 2024 Cantor Fitzgerald Global Healthcare Conference being held in New York City on September 17 – 19, 2024 (Press release, ALX Oncology, SEP 9, 2024, View Source [SID1234646419]).

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Format: Fireside chat with analyst, Li Watsek and 1×1 meetings
Date: Tuesday, September 17, 2024
Time: 1:55 PM ET
Webcast link: Available here

The live webcast of the fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at Events under the News and Events tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

On September 9, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported that it will hold its first Ovarian Cancer R&D Day on September 18, 2024 at the Harvard Club (35 West 44th Street) in New York City (Press release, IMUNON, SEP 9, 2024, View Source [SID1234646434]). The event will feature presentations and updates on the development program for IMNN-001, Imunon’s investigational therapy currently in development for the treatment of ovarian cancer. Presentations from KOLs including clinical study investigators, immunology and biostatistics experts and company management will take place from 10:00 a.m. to 12:00 p.m. Eastern time, followed by lunch and informal conversations with presenters from 12:00 p.m. to 1:00 p.m. Eastern time.

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Plans for the Ovarian Cancer R&D Day event follow IMUNON’s recent announcement of positive topline data from its randomized Phase 2 OVATION 2 Study of IMNN-001 showing that treatment was associated with an 11.1 month increase in median OS in the intent-to-treat population, representing a 35% improvement in survival among patients with advanced disease.

The R&D Day program will include insights from thought leaders with expertise in ovarian cancer and immunology and principal investigators from IMNN-001 clinical studies. The agenda will include a review of the OVATION 2 Study results, assessments of oncology clinical trial endpoints and a discussion of the potential role of IMNN-001 in the treatment of advanced ovarian cancer. In addition, IMUNON management will review next steps in the development program for IMNN-001 and the potential impact treatment could have on standard of care.

Presenters during the R&D Day event will include (listed in order of presentations):

Sid Kerkar, M.D., T cell biology review editor, Frontiers in Immunology. Dr. Kerkar will discuss the important role of IL-12 in treating cancer.
William Bradley, M.D., Professor, Obstetrics and Gynecology, Gynecologic Oncology, Medical College of Wisconsin. Dr. Bradley will discuss the data highlighting the safety and efficacy of IMNN-001.
L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health. Dr. Wei will discuss the opportunity to combine PFS and OS to provide a clinically interpretable evaluation of the IMNN-001 treatment effect.
Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Jazaeri will discuss the ongoing Phase 1/2 study of IMNN-001 in combination with bevacizumab in advanced ovarian cancer, for which he serves as principal investigator, including the importance of minimal residual disease and early translational insights.
Premal Thakker, M.D, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Interim Director of Gynecologic Oncology Clinical Research, Professor of Gynecologic Oncology, Washington University School of Medicine, and the OVATION 2 Study Chair. Dr. Thaker will discuss the OVATION 2 topline results and their clinical significance beyond the reported topline results.
IMUNON executives at the R&D Day event will include:

Stacy R. Lindborg, Ph.D., President and CEO, will provide an overview of treatment for women newly diagnosed with ovarian cancer and discuss how IMNN-001 has the potential to change the paradigm as well as planning for a Phase 3 registration study.
Khursheed Anwar, Ph.D., Chief Scientific Officer, will review the company’s TheraPlas technology platform, among other topics.
IMUNON strongly encourages in-person attendance to facilitate networking and direct engagement with speakers and management. For those unable to attend in person, a webcast will be available using the same registration link as above.

OVATION 2 Study Topline Results

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT.

As announced on July 30, 2024, highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:

An 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat population (ITT).
A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.
Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.
For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm.
About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On September 9, 2024 AbbVie (NYSE: ABBV) reported that new data from its innovative antibody-drug conjugate (ADC) platform will be showcased at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (September 13-17, 2024) (Press release, AbbVie, SEP 9, 2024, View Source [SID1234646450]). Presentations include data on mirvetuximab soravtansine (ELAHERE) and c-Met targeting ADCs, telisotuzumab vedotin (Teliso-V) and telisotuzumab adizutecan (ABBV-400). AbbVie’s ADCs are designed to target protein biomarkers such as folate receptor-alpha (FRα) and c-Met (MET protein) which are over expressed across various tumor types and are associated with poor prognoses.1-9 The ADCs are designed to deliver potent cancer cell-death inducing agents called ‘payloads’ specifically to the tumor, by utilizing these biomarkers as targets.

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Data from the primary analysis of the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine monotherapy in heavily pre-treated patients with FRα positive, platinum-sensitive ovarian cancer (PSOC) showed that the trial met its primary endpoint with an objective response rate (ORR) of 51.9% (95% CI 40.4, 63.3), including 6 complete and 35 partial responses. Among the 79 enrolled patients, 81% had prior poly (ADP-ribose) polymerase inhibitors (PARPi) treatment; 74.7% of whom progressed while on PARPi. The median duration of response (DOR), a key secondary endpoint, was 8.3 months (95% CI 5.5, 10.8) and median progression-free survival (PFS), an additional secondary endpoint, was 6.9 months (95% CI 5.9, 9.6). The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. The most common treatment-emergent adverse events (TEAEs) (grade ≥ 3) were blurred vision (10%), dry eye (3%), nausea (1%), keratopathy (4%), and diarrhea (3%). Additional data will be presented at the meeting.

"There is an urgent patient-driven unmet need to identify novel, effective and tolerable therapies for patients with platinum-sensitive ovarian cancer, including the PARPi pre-treated setting where diminished response to subsequent platinum-based chemotherapy has been reported," said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. "The response rate seen with mirvetuximab soravtansine in PICCOLO highlights the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients."

Mirvetuximab soravtansine is also being studied in PSOC in the Phase 3 GLORIOSA trial (NCT05445778), in combination with bevacizumab versus bevacizumab alone, in maintenance after second-line platinum-doublet therapy. Additionally, a Phase 2 study IMGN853-0420 (NCT05456685), is investigating the combination of mirvetuximab soravtansine with carboplatin as second-line treatment of PSOC with a wider range of FRα expression.

Patient reported outcome (PRO) data from the Phase 2 LUMINOSITY trial of Teliso-V, in c-Met protein overexpressing, epidermal growth factor receptor (EGFR) wild type, advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) patients, will be presented at the meeting. Trends in PROs observed in LUMINOSITY will be further evaluated in the ongoing Phase 3 TeliMET NSCLC-01 trial (NCT04928846).

"The data at ESMO (Free ESMO Whitepaper) showcase the depth of our ADC pipeline and highlights the significant progress we are making across key programs in various stages of development, as we strive to deliver new and innovative medicines for patients in need," said Daejin Abidoye, M.D., vice president, head of solid tumors, oncology development, AbbVie. "A testament to these efforts is our plan to submit Teliso-V for accelerated approval as a monotherapy in patients with previously treated c-Met overexpressing, epidermal growth factor receptor (EGFR) wild-type non-squamous non-small cell lung cancer in Q3 2024."

The accelerated approval submission for Teliso-V will be reviewed under FDA’s real-time oncology review program with an approval decision anticipated in 2025. AbbVie announced FDA breakthrough therapy designation for Teliso-V in 2022.

New safety and efficacy data from a Phase 1 study (NCT05029882) of ABBV-400, a next-generation, potential best-in-class c-Met directed ADC, highlights the potential of ABBV-400 in previously-treated NSCLC and gastroesophageal cancer (GEA) patients, and are supportive of further exploration of this novel ADC in these tumor types and other solid tumors:

Preliminary data show that among 48 previously treated EGFR wild type non-squamous NSCLC patients, antitumor activity was observed with ABBV-400 when dosed at 2.4 and 3.0 mg/kg administered once every 3 weeks (n=39 and 9, respectively), with a confirmed ORR of 43.8% and clinical benefit rate of 85.4%. The most common (≥10%) TEAEs (grade ≥ 3) were anemia (25%) and neutropenia (15%). Additional endpoints (such as progression free survival), association between c-Met protein expression and treatment response, and detailed safety data will be presented at the meeting.
In GEA patients, the preliminary data show that among 42 patients, antitumor activity was observed at a dose of ABBV-400 of 3.0 mg/kg administered once every 3 weeks, with confirmed ORR of 28.6%. The clinical benefit rate was 71.4%. The most common (≥20%) TEAEs (any grade) were gastrointestinal (76.2%), anemia (66.7%), nausea (47.6%), thrombocytopenia and constipation (26.2% each) and neutropenia (23.8%). Additional safety and efficacy data will be presented at the meeting.
ABBV-400 is also being evaluated in a Phase 1b basket study (NCT06084481) in advanced solid tumors as a monotherapy and a Phase 2 study (NCT06107413) in second line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid, and bevacizumab.

Teliso-V and ABBV-400 both target c-Met with the same parental antibody but have different designs and mechanisms of action.10,11 Teliso-V, AbbVie’s most advanced c-Met targeted ADC in development, utilizes a microtubule polymerization inhibitor (MMAE) payload.10 ABBV-400, a next-generation c-Met targeted ADC utilizes a novel, proprietary topoisomerase 1 inhibitor (Top1i) payload.11

AbbVie will also present real-world data on the prevalence, stability, and prognostic value of c-Met protein overexpression in NSCLC from the METPRO and METEXPRESS studies at the meeting.

Further information on AbbVie clinical trials is available at View Source

Additional details on key presentations at ESMO (Free ESMO Whitepaper) are available below:

Title

Date/Time

Session

Abstract
number

Mirvetuximab soravtansine (MIRV) in
recurrent platinum-sensitive ovarian
cancer (PSOC) with high folate receptor-
alpha (FRα) expression: Results from
the PICCOLO trial

Sept 15,
15:20-15:25 CEST

Mini oral session

Gynaecological cancers
(Santander Auditorium, Hall 5)

718MO

Patient-reported outcomes (PROs) in the
LUMINOSITY trial: Evaluating
telisotuzumab vedotin (Teliso-V) in
patients (Pts) with c-Met protein
overexpressing (OE), EGFR wildtype,
non-squamous non-small cell lung
cancer (NSQ NSCLC)

Sept 14

Poster

NSCLC, metastatic

1313P

ABBV-400, a c-Met protein–targeting
antibody-drug conjugate (ADC), in
patients (Pts) with advanced EGFR
wildtype (WT) non-squamous (NSQ)
non-small cell lung cancer (NSCLC):
Results from a phase 1 study

Sept 14,

10:45 – 10:50 CEST

Mini oral session

NSCLC metastatic
(Santander Auditorium,
Hall 5)

1257MO

ABBV-400, a c-Met protein–targeting
antibody-drug conjugate (ADC), in
patients (pts) with advanced
gastric/gastroesophageal junction
adenocarcinoma (GEA): Results from a
phase 1 study

Sept 16

Poster

Oesophagogastric cancer

1439P

METPRO: Evaluating prognostic
value of c-Met protein overexpression
and concurrent biomarker presence

Sept 14

Poster

NSCLC, metastatic

1303P

Consistency analysis of c-Met protein
expression over time in patients with
non-squamous non-small cell lung
cancer

Sept 15

Poster

Biomarkers and
translational research
(agnostic)

165P

About the PICCOLO trial
PICCOLO is a single-arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy. The primary end point is objective response rate (ORR), and the key secondary endpoint is duration of response (DOR).

The PICCOLO study was designed to statistically rule out an objective response rate of 28% or lower, as excluded by the lower bound of the confidence interval, a response rate which has been observed with non-platinum, single-agent chemotherapy in platinum-sensitive disease. Patients with PSOC with multiple prior lines of platinum-based therapy or who are ineligible for platinum-based therapy, as in the population in PICCOLO, have no established benchmark standard of care, particularly after disease progression on a PARP inhibitor.

AbbVie previously announced positive topline results from the study in June 2024.

About the LUMINOSITY trial
The LUMINOSITY trial (M14-239), is an ongoing single-arm Phase 2 study designed to identify the target NSCLC populations that overexpress c-Met best suited for Teliso-V monotherapy in the second line or third line setting, and then to expand the groups to further evaluate efficacy in the selected populations. The endpoints include overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and progression-free survival (PFS) per independent central review (ICR) as well as overall survival (OS). AbbVie previously announced positive topline results from the LUMINOSITY study in November 2023.

About Mirvetuximab soravtansine
Mirvetuximab soravtansine is a first-in-class 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.

The Marketing Authorization Application (MAA) for mirvetuximab soravtansine in Europe has been accepted by the European Medicines Agency (EMA) and regulatory submissions are also under review in multiple other countries. The safety and efficacy of mirvetuximab soravtansine has not been established for platinum-sensitive ovarian cancer.

ELAHERE (mirvetuximab soravtansine-gynx) U.S. INDICATION and IMPORTANT SAFETY INFORMATION
ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
Administer prophylactic artificial tears and ophthalmic topical steroids.
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
Discontinue ELAHERE for Grade 4 ocular toxicities.
WARNINGS and PRECAUTIONS
Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).

The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation
Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

Please see full Prescribing Information, including BOXED WARNING