On October 27, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported it will report financial results for the third quarter of 2022 after market close on Thursday, November 10, 2022 (Press release, Pulse Biosciences, OCT 27, 2022, View Source [SID1234622525]). Company management will host a corresponding conference call beginning at 1:30pm PT / 4:30pm ET.

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Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On October 27, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations (Press release, Clovis Oncology, OCT 27, 2022, View Source [SID1234622524]). The presentation titled, "TRITON3: A Phase 3 Study of Rucaparib vs. Physician’s Choice of Therapy in mCRPC Associated with Homologous Recombination Deficiency (HRD)" is being presented by Alan H. Bryce, MD, chair of the Division of Hematology and Medical Oncology at the Mayo Clinic and co-principal investigator of the TRITON3 trial during the session titled, "Novel Clinical Trial Updates" at the 29th Annual Prostate Cancer Foundation (PCF) Scientific Retreat.

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The presentation is available at View Source

"We believe that the positive results from TRITON3 further demonstrate the important role that Rubraca may play as a treatment option for men with metastatic castration-resistant prostate cancer associated with homologous recombination deficiency. This is the first and only PARP inhibitor that has demonstrated superior radiographic PFS compared to a control arm containing docetaxel chemotherapy, which is today the standard of care for these patients," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to submitting additional data for presentation during a medical meeting in 2023."

Earlier this month, the Company reported top-line data from the TRITON3 (NCT02975934) study evaluating Rubraca monotherapy versus chemotherapy or second-line second-generation androgen pathway inhibitor in patients with chemotherapy-naive mCRPC with mutations in BRCA or ATM achieved the primary endpoint of improved radiographic progression-free survival (rPFS) by independent radiology review (IRR).

About the TRITON3 Clinical Trial

TRITON3 (NCT02975934) is a Phase 3, multicenter, open-label, randomized trial of Rubraca in patients with chemotherapy-naïve mCRPC. Patients with a mutation in BRCA or ATM were randomized to Rubraca or the control group, which consisted of physician’s choice of docetaxel, abiraterone acetate, or enzalutamide. The primary objective was efficacy, as analyzed by independent radiology review (IRR) of radiographic progression-free survival (rPFS) in patients with mutations in BRCA1, BRCA2 or ATM. TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting against a relevant control arm.

About Prostate Cancer

The American Cancer Society estimates that approximately 268,000 men in the US will be diagnosed with prostate cancer in 2022, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 473,000 men in Europe were diagnosed with prostate cancer in 2020. Castrate-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castrate-resistant prostate cancer (mCRPC) is an incurable disease, usually associated with poor prognosis.i Approximately 43,000 men in the US were expected to be diagnosed with mCRPC in 2020.ii According to the National Cancer Institute, the five-year survival rate for mCRPC is approximately 30%. BRCA1, BRCA2 or ATM mutations have been detected in approximately 19% of patients with mCRPC according to articles published in JCO Precision Oncology in 2017 and in Clinical Cancer Research in 2021. These molecular markers may be used to select patients for treatment with a PARP inhibitor.iii

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca is an unlicensed medical product outside of the US and Europe.

Rubraca US FDA Approved Indications

Ovarian Cancer

Rubraca is indicated for the maintenance treatment of adult women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Prostate Cancer

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have occurred in patients treated with Rubraca and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28-day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

On October 27, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from two studies demonstrating the potential of DecisionDx-Melanoma and DecisionDx-UM to accurately stratify risk of death from melanoma (cutaneous melanoma (CM) and uveal melanoma (UM), respectively) in a group of real-world, unselected and prospectively tested patients (Press release, Castle Biosciences, OCT 27, 2022, View Source [SID1234622523]). The studies are part of the Company’s ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma and DecisionDx-UM clinical testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM and UM cases, respectively. The data were shared in poster presentations at the 19th International Congress of the Society for Melanoma Research (SMR) in Edinburgh, United Kingdom.

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"Castle is committed to providing innovative and clinically actionable tests that can guide more informed and more personalized treatment decisions," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our DecisionDx family of GEP tests has clinical value, and the studies that we have done in collaboration with the NCI’s SEER Program provide a unique opportunity to demonstrate their performance, specifically DecisionDx-Melanoma and DecisionDx-UM, in real-world patients with known survival outcomes."

DecisionDx-Melanoma | Poster #: P- 036

Improving patient selection for adjuvant therapy: Considerations for the role of the 31-gene expression profile test

Pembrolizumab (KEYTRUDA) received expanded FDA approval as an adjuvant therapy for patients with stage IIB-IIC melanoma in late Dec. 2021 but is associated with a high adverse-event rate, suggesting that the benefit-to-risk ratio for patient selection could be improved by identifying patients who would have high survival rates without therapy. The study evaluated the risk stratification performance of DecisionDx-Melanoma in a group of real-world, unselected and prospectively tested patients with stage I-III CM in the SEER registry (n=4,687), including stage IIB-IIC patients who could potentially benefit from better selection for adjuvant therapy.

In the study, DecisionDx-Melanoma was a statistically significant and independent predictor of melanoma-specific survival (MSS), consistent with previously published retrospective and prospective studies. Patients with stage IIB or IIC melanoma and a low-risk (Class 1A) DecisionDx-Melanoma test result had higher three-year MSS than patients with a high-risk (Class 2B) result (Class 1A: 100% vs. Class 2B: 88.3%, p=0.04); similar results were observed for patients with stage III CM (Class 1A: 96.1% vs. Class 2B; 79.6%, p=0.03). Additionally, DecisionDx-Melanoma was a statistically significant and independent predictor of MSS across all stages of disease, with a hazard ratio of 7.00 for the Class 2B result. Overall, the study data show that DecisionDx-Melanoma can identify patients with a low risk of death from CM who could potentially forego unnecessary adjuvant therapies, thereby reducing healthcare costs and adjuvant therapy-related adverse events; conversely, the test can identify patients who are at a much higher likelihood of progressing, potentially enabling more aggressive decisions regarding the use of adjuvant therapy.

The poster may be viewed here.

DecisionDx-UM | Poster #: P- 035

A collaborative outcome study in uveal melanoma with the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program Registries (NCI SEER): Performance of the 15-gene expression profile test in clinically tested uveal melanoma patients

The study evaluated the risk-stratification performance of DecisionDx-UM in a real-world, unselected, clinically tested cohort of patients with UM (n=615). On behalf of the SEER registries, a third-party honest broker conducted a linkage of all patients with UM from 16 NCI SEER registries to those clinically tested with DecisionDx-UM. The study included all linked cases diagnosed in 2018 with survival outcome information and a DecisionDx-UM test result. Patients with stage IV disease (evidence of distant metastasis) at initial presentation were excluded from the analysis.

In the study, DecisionDx-UM accurately stratified patient risk of death from UM. Patients with a low-risk (Class 1A) DecisionDx-UM test result had higher 18-month overall survival (OS) and 18-month MSS than patients with a high-risk (Class 2) test result (OS=97.1% vs. 86.2%, P=0.02; MSS= 98.9% vs. 92.7%; P=0.02). Additionally, patients with a high-risk DecisionDx-UM test result had a ten-fold higher risk of death from UM than patients with a low-risk test result (hazard ratio=10.06, p=0.033). Overall, the study data confirm the accurate risk-stratification performance of DecisionDx-UM shown in previously published studies, which is important for guiding management decisions regarding the frequency of follow-up and metastatic surveillance imaging, as well as participation in clinical trials.

The poster may be viewed here.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma. DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type. It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.CastleTestInfo.com.

On October 27, 2022 Novocure (NASDAQ: NVCR) reported that financial results for the quarter ended September 30, 2022. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields) (Press release, NovoCure, OCT 27, 2022, View Source [SID1234622522]).

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"In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer"

"In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer," said William Doyle, Novocure’s Executive Chairman. "We are diligently working to reach additional patients in our current markets, expand into new markets, enhance our products and treat patients in new indications throughout the body. We are investing aggressively to prepare Novocure for the future and are eager to treat many more patients in the coming years."

"Novocure is approaching a period that should be transformational for our company and patients," said Asaf Danziger, Novocure’s Chief Executive Officer. "January marks the beginning of a two-year period of multiple data releases from our pivotal studies exploring the use of TTFields in a variety of solid tumor cancers and combinations. These data catalysts could enable us to treat tens of thousands more patients in the future, and we look forward to sharing these results with physicians, patients, and the investor community in the coming quarters."

Financial updates for the third quarter ended September 30, 2022:

Total net revenues for the quarter were $131.0 million, a decrease of 2% compared to the same period in 2021.
The United States, EMEA and Japan contributed $102.7 million, $14.3 million, and $7.9 million in quarterly net revenues, respectively.
Net revenues were impacted by the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage updates and foreign exchange pressure.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $6.2 million.
Gross margin for the quarter was 77%.
Research, development and clinical studies expenses for the quarter were $52.0 million, an increase of 8% from the same period in 2021.
Sales and marketing expenses for the quarter were $41.4 million, an increase of 27% compared to the same period in 2021. This reflects increased investments in early commercial and market access capabilities.
General and administrative expenses for the quarter were $32.5 million, an increase of 4% compared to the same period in 2021.
Net loss for the quarter was $26.6 million with loss per share of $0.25.
Adjusted EBITDA* for the quarter was $4.4 million.
Cash, cash equivalents and short-term investments were $970.3 million as of September 30, 2022.
Operational updates for the third quarter ended September 30, 2022:

As of September 30, 2022, there were 3,420 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,181, 885 and 354 active patients, respectively.
1,389 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 978, 332 and 79 prescriptions, respectively.
Quarterly updates and achievements:

Today, we are announcing preliminary data from the phase 2 EF-33 pilot study evaluating the safety and efficacy of high density arrays in 25 patients with recurrent glioblastoma (GBM). Among those who used Optune as directed for at least one month, median progression-free survival was 4.5 months compared to 2.2 months in the historical control, Novocure’s pivotal EF-11 study. Further, notwithstanding the increased TTFields intensity, EF-33 patients reported no TTFields-related toxicity.
Our phase 3 pivotal METIS study for the treatment of brain metastases from non-small cell lung cancer (NSCLC) continues to enroll well, and we have visibility to final patient enrollment; however, we now expect to complete enrollment in the first quarter of 2023 versus the fourth quarter of 2022. This will begin the final patient’s 12-month follow-up period, and we anticipate top-line data in the first quarter of 2024.
In September 2022, we announced the creation of our U.S. CNS (central nervous system) Cancers Franchise, intended to strengthen focus on growth in our U.S. GBM business by streamlining decision-making and improving coordination.
Anticipated clinical milestones:

Top-line readout from phase 3 pivotal LUNAR study in NSCLC cancer (Q1 2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2024)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2022 financial results at 8 a.m. EDT today, Thursday, October 27, 2022. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 27, 2022 Ignyte Acquisition Corp. ("Ignyte") (NASDAQ: IGNY), a publicly traded special purpose acquisition company, reported that Ignyte’s stockholders have approved its proposed business combination (the "Business Combination") with Peak Bio Co., Ltd. ("Peak Bio") at a Special Meeting of its stockholders held on October 25, 2022 (the "Special Meeting") (Press release, Ignyte Acquisition, OCT 27, 2022, View Source [SID1234622521]). The Special Meeting to be held on October 31, 2022 has been canceled.

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Approximately 75% of the votes cast at the Special Meeting, representing approximately 75% of Ignyte’s outstanding shares of common stock entitled to vote at the Special Meeting, were cast in favor of the proposal to approve the Business Combination with Peak Bio. The formal results of the Special Meeting will be included in a Current Report on Form 8-K to be filed by Ignyte with the Securities and Exchange Commission (the "SEC").