Seagen to Highlight Research in Urothelial Cancer at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium

On February 13, 2023 Seagen Inc. (Nasdaq: SGEN) reported the presentation of new data featuring PADCEV (enfortumab vedotin-ejfv) at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU) taking place from February 16-18, 2023 (Press release, Seagen, FEB 13, 2023, View Source [SID1234627120]). A podium presentation will feature noteworthy patient-reported outcomes from the registrational Phase 1b/2 EV‐103 Cohort K study.

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Cohort K is evaluating enfortumab vedotin developed in partnership with Astellas, as monotherapy and in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-based chemotherapy. Merck is known as MSD outside the United States and Canada.

"Patients are at the heart of the work we do, and we are committed to developing innovative solutions for people with urothelial cancer and challenging clinical needs," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. "We look forward to presenting patient-reported outcomes for PADCEV at ASCO (Free ASCO Whitepaper) GU, and further addressing unmet needs that people with cancer experience in order to better support this community and increase their quality of life."

Other notable data that will be presented from Seagen’s sponsored research include subgroup analyses of the confirmed objective response rate by investigator assessment from the EV‐103 Cohort K study, along with qualitative insights from patients, caregivers and physicians and data from real-world studies. Trials in progress for enfortumab vedotin in non-muscle invasive and muscle-invasive bladder cancer will also be featured in poster presentations at the meeting, showcasing Seagen’s engagement across a broad spectrum of urothelial cancers.

Key data presentations for Seagen include:

Presentations of Company-Sponsored Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Enfortumab Vedotin

Patient‐reported outcomes (PROs) in cisplatin‐ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC) treated with enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in the Phase 1b/2 EV‐103 Cohort K study

439

Podium Presentation
Friday, Feb. 17

3:45-3:55 p.m. PT

Panel Discussion

3:55 p.m. PT

M. Milowsky

Enfortumab vedotin (EV) alone or in combination w/ pembrolizumab (P) in previously untreated cisplatin‐ineligible patients w/ locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR) from EV‐103 Cohort K

499

Poster Session

Friday, Feb. 17

12:30-2 p.m. PT

5:15-6:15 p.m. PT

P. O’Donnell

Understanding drivers of treatment preferences in locally advanced or metastatic urothelial carcinoma: A qualitative interview study with patients, caregivers, and physicians

492

Poster Session
Friday, Feb. 17

12:30-2 p.m. PT

5:15-6:15 p.m. PT

A. Apolo

Real‐World treatment and quality of life (QOL) in locally advanced or metastatic urothelial carcinoma (la/mUC) in Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey

462

Poster Session
Friday, Feb. 17

12:30-2 p.m. PT

5:15-6:15 p.m. PT

L. Cheng

Real‐World treatment patterns, survival outcomes, and health care resource utilization (HCRU) for Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) in Spain

463

Poster Session
Friday, Feb. 17

12:30-2 p.m. PT

5:15-6:15 p.m. PT

J. Puente

Disitamab Vedotin

Systematic literature review and testing of HER2 status in urothelial carcinoma (UC)

556

Poster Session
Friday, Feb. 17

12:30-2 p.m. PT

5:15-6:15 p.m. PT

V. Koshkin

Presentations of Company-Sponsored Trials in Progress

Abstract Title

Abstract #

Presentation Type

Lead Author

Enfortumab Vedotin

Study EV‐104: Phase 1 study of intravesical enfortumab vedotin for treatment of patients with non‐muscle invasive bladder cancer (NMIBC) (Encore)

(TIP)

TPS582

Poster Session
Friday, Feb. 17

12:30 p.m. PT

A. Kamat

Phase 3 KEYNOTE‐905/EV‐303: Perioperative pembrolizumab (pembro) or pembro + enfortumab vedotin (EV) for muscle‐invasive bladder cancer (MIBC) (Encore) (TIP)

TPS585

Poster Session
Friday, Feb. 17

12:30 p.m. PT

A. Necchi

Perioperative enfortumab vedotin (EV) plus pembrolizumab (pembro) versus chemotherapy in cisplatin‐eligible patients (pts) with muscle‐invasive bladder cancer (MIBC): Phase 3 KEYNOTE‐B15/EV‐304 (Encore) (TIP)

TPS588

Poster Session
Friday, Feb. 17

12:30 p.m. PT

C. Hoimes

Tucatinib

A Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations: urothelial cancer cohort (TIP)

TPS587

Poster Session
Friday, Feb. 17

12:30 p.m. PT

E. Yu

Disitamab Vedotin

A Phase 2 clinical study evaluating the efficacy and safety of disitamab vedotin with or without pembrolizumab in patients with HER2-expressing urothelial carcinoma (TIP)

TPS594

Poster Session
Friday, Feb. 17

12:30 p.m. PT

T. Powles

About Enfortumab Vedotin

Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.i,ii Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).i

PADCEV (enfortumab vedotin-ejfv) U.S. Indication & Important Safety Information
BOXED WARNING: SERIOUS SKIN REACTIONS

PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
Closely monitor patients for skin reactions.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
Indication

PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who:

have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.iii
Important Safety Information
Warnings and Precautions

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN, occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 55% of the 680 patients treated with PADCEV in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 33% had pruritus. Grade 3-4 skin reactions occurred in 13% of patients, including maculo-papular rash, rash erythematous, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), dermatitis bullous, dermatitis exfoliative, and palmar-plantar erythrodysesthesia. In clinical trials, the median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 6.4). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=59), 24% of patients restarting at the same dose and 16% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 2.6% of patients. Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. Withhold PADCEV and refer for specialized care for suspected SJS or TEN or for severe (Grade 3) skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN, or for Grade 4 or recurrent Grade 3 skin reactions.

Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials, 14% of the 680 patients treated with PADCEV developed hyperglycemia; 7% of patients developed Grade 3-4 hyperglycemia. The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. The median time to onset of hyperglycemia was 0.6 months (range: 0.1 to 20.3). Hyperglycemia led to discontinuation of PADCEV in 0.6% of patients. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.

Pneumonitis Severe, life-threatening or fatal pneumonitis occurred in patients treated with PADCEV. In clinical trials, 3.1% of the 680 patients treated with PADCEV had pneumonitis of any grade and 0.7% had Grade 3-4. In clinical trials, the median time to onset of pneumonitis was 2.9 months (range: 0.6 to 6). Monitor patients for signs and symptoms indicative of pneumonitis, such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis.

Peripheral neuropathy (PN) occurred in 52% of the 680 patients treated with PADCEV in clinical trials, including 39% with sensory neuropathy, 7% with muscular weakness and 6% with motor neuropathy; 4% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.6 months (range: 0.1 to 15.8 months). Neuropathy led to treatment discontinuation in 5% of patients. Monitor patients for symptoms of new or worsening peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.

Ocular disorders were reported in 40% of the 384 patients treated with PADCEV in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 34% of patients, and blurred vision occurred in 13% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.6 months (range: 0 to 19.1 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.

Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 680 patients, 1.6% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.

Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.

Adverse Reactions
Most Common Adverse Reactions, Including Laboratory Abnormalities (≥20%)

Rash, aspartate aminotransferase (AST) increased, glucose increased, creatinine increased, fatigue, PN, lymphocytes decreased, alopecia, decreased appetite, hemoglobin decreased, diarrhea, sodium decreased, nausea, pruritus, phosphate decreased, dysgeusia, alanine aminotransferase (ALT) increased, anemia, albumin decreased, neutrophils decreased, urate increased, lipase increased, platelets decreased, weight decreased and dry skin.

EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy.

Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each) and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1.0%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%) and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite and fatigue (3% each). Clinically relevant adverse reactions (<15%) include vomiting (14%), AST increased (12%), hyperglycemia (10%), ALT increased (9%), pneumonitis (3%) and infusion site extravasation (0.7%).

EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for platinum-based chemotherapy.

Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia and pneumonitis (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), AST increased and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%) and fatigue (7%). Clinically relevant adverse reactions (<15%) include vomiting (13%), AST increased (12%), lipase increased (11%), ALT increased (10%), pneumonitis (4%) and infusion site extravasation (1%).

Drug Interactions
Effects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)

Concomitant use with a dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.

Specific Populations

Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for at least 3 weeks after the last dose.

Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.

Medpace Holdings, Inc. Reports Fourth Quarter and Full Year 2022 Results

On February 13, 2023 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Medpace, FEB 13, 2023, View Source [SID1234627141]).

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Fourth Quarter 2022 Financial Results

Revenue for the three months ended December 31, 2022 increased 27.7% to $394.1 million, compared to $308.6 million for the comparable prior-year period. On a constant currency organic basis, revenue for the fourth quarter of 2022 increased 28.9% compared to the fourth quarter of 2021.

Backlog as of December 31, 2022 increased 17.2% to $2,339.6 million from $1,997.1 million as of December 31, 2021. Net new business awards were $485.1 million, representing a net book-to-bill ratio of 1.23x for the fourth quarter of 2022, as compared to $458.7 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the fourth quarter of 2022, total direct costs were $278.4 million, compared to total direct costs of $220.6 million in the fourth quarter of 2021. Selling, general and administrative (SG&A) expenses were $33.4 million in the fourth quarter of 2022, compared to SG&A expenses of $27.7 million in the fourth quarter of 2021.

GAAP net income for the fourth quarter of 2022 was $68.7 million, or $2.12 per diluted share, versus GAAP net income of $50.0 million, or $1.32 per diluted share, for the fourth quarter of 2021. This resulted in a net income margin of 17.4% and 16.2% for the fourth quarter of 2022 and 2021, respectively.

EBITDA for the fourth quarter of 2022 increased 30.9% to $80.4 million, or 20.4% of revenue, compared to $61.4 million, or 19.9% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the fourth quarter of 2022 increased 23.3% from the fourth quarter of 2021.

Full Year 2022 Financial Results

Revenue for the year ended December 31, 2022 increased 27.8% to $1,460.0 million, compared to $1,142.4 million for the year ended December 31, 2021. On a constant currency organic basis, revenue increased 29.2% for the year ended December 31, 2022 compared to the year ended December 31, 2021.

For the year ended December 31, 2022, net new business awards were $1,829.5 million, representing a net book-to-bill ratio of 1.25x, compared to $1,610.4 million for the year ended December 31, 2021.

For the full year 2022, total direct costs were $1,027.6 million, compared to $814.2 million in the full year 2021. For the full year 2022, SG&A expenses were $131.4 million, compared to $108.4 million for the full year 2021.

GAAP net income for the full year 2022 was $245.4 million, or $7.28 per diluted share, versus GAAP net income of $181.8 million, or $4.81 per diluted share, for the full year 2021. This resulted in a net income margin of 16.8% and 15.9% for the full year 2022 and 2021, respectively.

EBITDA for the full year 2022 increased 38.1% to $308.1 million, or 21.1% of revenue, compared to $223.1 million, or 19.5% of revenue, for the prior year. On a constant currency basis, EBITDA increased 32.3% for the full year 2022 compared to the full year 2021.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA and EBITDA margin to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $28.3 million at December 31, 2022, and the Company generated $136.7 million in cash flow from operating activities during the fourth quarter of 2022. The Company paid $89.7 million against the credit facility during the fourth quarter of 2022. Short-term debt was $50.0 million at December 31, 2022.

During the fourth quarter of 2022, the Company repurchased 228,247 shares at an average price of $206.68 per share for a total of $47.2 million. For the full year 2022, the Company repurchased approximately 5.7 million shares for $847.7 million. As of December 31, 2022, the Company had $452.8 million remaining under its authorized share repurchase program.

2023 Financial Guidance

The Company forecasts 2023 revenue in the range of $1.690 billion to $1.750 billion, representing growth of 15.8% to 19.9% over 2022 revenue of $1.460 billion. GAAP net income for full year 2023 is forecasted in the range of $245.0 million to $265.0 million. Additionally, full year 2023 EBITDA is expected in the range of $325.0 million to $350.0 million. Based on forecasted 2023 revenue of $1.690 billion to $1.750 billion and GAAP net income of $245.0 million to $265.0 million, diluted earnings per share (GAAP) is forecasted in the range of $7.53 to $8.14. This guidance assumes a full year 2023 tax rate of 17.5% to 18.5% and does not reflect the potential impact of any share repurchases the Company may make pursuant to the share repurchase program after December 31, 2022.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, February 14, 2023, to discuss its fourth quarter and full year 2022 results.

To participate in the conference call, interested parties must register in advance by clicking on this link. While it is not required, it is recommended you join 10 minutes prior to the event start. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique PIN that can be used to access the call.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call. A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

SOPHiA GENETICS Expands Partnership With AstraZeneca to Include Multimodal Approaches for Cancer Drug Development

On February 13, 2023 SOPHiA GENETICS SA (Nasdaq: SOPH), the creator of a leading cloud-native global data-sharing network and health analytics platform,reported that it is partnering with AstraZeneca (LSE/STO/Nasdaq: AZN) to apply their multimodal technology and expertise to the biopharmaceutical company’s oncology portfolio (Press release, Sophia Genetics, FEB 13, 2023, View Source [SID1234627140]). The multimodal approach will go beyond a single data modality, combining radiomics analysis of medical imaging data, molecular data, digital pathology, clinical and biologic data for a more comprehensive assessment of multimodal signatures leveraging proprietary AI and machine learning technology. Together, the companies will examine ways to accelerate clinical trials, support evidence generation for market access, and improve clinical decision-making, helping clinicians to select the best possible treatments.

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SOPHiA GENETICS is able to support this vision in practice today. In parallel, SOPHiA GENETICS launched its own real-world DEEP-Lung-IV clinical study to leverage its multimodal machine learning-powered analytics capabilities to identify multimodal predictive signatures of response to immunotherapy for patients with advanced lung cancer.

"AstraZeneca is a global leader in innovative oncology therapeutics and has built one of the most diverse and robust oncology portfolios and R&D pipelines in the industry. Building on our existing partnership with AstraZeneca, notably to expand access to HRD testing, we are incredibly excited to deepen our collaboration to multimodal approaches that will further enable their precision oncology capabilities," said Peter Casasanto, Chief BioPharma Officer of SOPHiA GENETICS.

"We see AstraZeneca as a visionary partner willing to invest in the next generation of data sciences and technology capabilities at scale to usher in a new area of data-driven medicine. We are incredibly excited to further integrate science and technology in our joint pursuit of transformative impact on patient outcomes," said Dr. Philippe Menu, Chief Medical Officer SOPHiA GENETICS.

"Multimodality aims to harness the power of advanced AI and machine learning models by integrating multiple data modalities to obtain key insights which inform prognosis and response to therapy at the individual patient level. This approach is synergistic with AstraZeneca’s focus on developing personalized cancer treatment and has the potential to elevate precision oncology, currently driven by genomic-based biomarkers, into a truly multimodal connected health ecosystem," said Greg Rossi, Senior Vice President, Oncology Europe & Canada, AstraZeneca.

Lytgobi® (futibatinib) Now Available from Onco360 for the Treatment of Adult Patients with Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Gene Fusions or Other Rearrangements

On February 13, 2023 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Taiho Oncology to be a specialty pharmacy partner for Lytgobi (futibatinib), which is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearranagements (Press release, Onco360, FEB 13, 2023, View Source [SID1234627138]). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Onco360 is honored to partner with Taiho Oncology and become a specialty pharmacy provider for Lytgobi patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of patients battling treatment-experienced, FGFR2-mutant, advanced cholangiocarcinoma patients across the United States."

According to the American Cancer Society (ACS), it is estimated that 8,000 patients will be diagnosed with cholangiocarcinoma annually. The five-year overall survival (OS) for cholangiocarcinoma, regardless of stage, is only 9%. With regard to cholangiocarcinoma patients with distant metastatic disease, the five-year OS is only 2%.1 Approximately 20% of cholangiocarcinoma cases are considered intrahepatic in terms of tumor location.2 10-16% of intrahepatic cholangiocarcinoma cases have FGFR2 mutations.3

Lytgobi is developed and commercialized by Taiho Oncology. The FDA approval of Lytgobi comes as a result of the Phase I/II, open-label, single-arm TAS-120-101 (NCT02052778) clinical trial which evaluated the use of Lytgobi in previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma patients. The TAS-120-101 demonstrated that Lytgobi administration resulted in a 42% overall response rate (ORR) in 103 study participants.

Cleveland Diagnostics Announces Agreement with Quest Diagnostics to Expand Patient Access to IsoPSA® Prostate Cancer Testing

On February 13, 2023 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, FEB 13, 2023, View Source [SID1234627137]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Through an agreement with Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, patients will be able to access IsoPSA and, once ordered by their physician, provide a blood specimen for testing at one of over 2,100 Quest Diagnostics patient service center locations nationwide later this year. With its national logistics network, Quest will transport the specimens to Cleveland Diagnostics’ laboratory for testing. The parties expect physicians will be able to begin offering the test to patients through Quest Diagnostics in the second quarter of 2023.

IsoPSA is a blood-based prostate cancer test used in triaging patients at risk for high-grade prostate cancer to biopsy. For patients with elevated levels of prostate-specific antigen (PSA), IsoPSA provides additional insight into whether patients’ elevated PSA levels are due to high-grade cancer or a different condition, thereby empowering physicians and patients with insights for deciding whether to undergo prostate biopsy.

PSA is a protein produced by cells of the prostate gland. While the PSA test measures the level of PSA in the blood, which is often elevated in people with prostate cancer, several benign conditions can also cause a person’s PSA level to rise.1 Moreover, PSA testing is unable to identify cases of prostate cancer that may be rapidly progressing and therefore require urgent treatment. By comparison, the IsoPSA test helps predict risk by interrogating the partitioning behavior of isoforms of PSA that are linked to cancer. In a large, prospective, multi-center clinical study, the IsoPSA test demonstrated significant improvement in detecting high grade prostate cancer.2 A separate and robust clinical utility study confirmed that IsoPSA could reduce unnecessary biopsies by as much as 55%.3

"We are very pleased to collaborate with Quest Diagnostics to expand patient access to IsoPSA. We believe Quest’s broad reach and extensive laboratory services expertise will provide patients and their physicians with unparalleled access to transformative clinical insights," said Arnon Chait, CEO of Cleveland Diagnostics. "As the leader in oncology testing, Quest is aligned with Cleveland Diagnostics’ vision of providing physicians and their patients exceptional and more definitive understanding of their prostate conditions."

"Prostate cancer is a leading cause of cancer – and cancer deaths – among men, and physicians are eager for improved tools to diagnose, stage and monitor this disease," said Kristie Dolan, vice president and general manager of Oncology at Quest Diagnostics. "We believe IsoPSA holds great promise to better inform physicians’ diagnostic and treatment decisions for their patients being evaluated for prostate cancer, and we are pleased to work with Cleveland Diagnostics to expand access to this important new test, ultimately bettering patient outcomes by improving the diagnostic process."

According to the American Cancer Society, prostate cancer increased by 3% per year from 2014 through 2019 after two decades of decline, driven primarily by the diagnosis of advanced disease.4 A recent Quest Diagnostics Health Trends study suggests this trend could continue or even worsen: two years after the COVID-19 pandemic began, the rate of new diagnoses of prostate cancer continued to lag behind pre-pandemic levels, suggesting delays in care may contribute to more advanced prostate cancers in the future.

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio. For the time being, tests ordered through the Quest network will be processed in Cleveland Diagnostics’ laboratory in Cleveland, OH.