On September 20, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the first half of 2021 (Press release, ERYtech Pharma, SEP 20, 2021, View Source [SID1234587988]).

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On September 20, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported results from a post hoc exploratory analysis of the Phase 2 study, MRTX-500. Results showed durable responses and long-term survival with sitravatinib in combination with nivolumab (OPDIVO)1 in patients with second or third line non-squamous non-small cell lung cancer (NSCLC) who experienced clinical benefit on a prior checkpoint inhibitor (CPI) and subsequent disease progression (n=68) (Press release, Mirati, SEP 20, 2021, View Source [SID1234588016]).

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The findings (Abstract # 1191O) will be presented in an oral presentation today at 8:20 a.m. ET during the NSCLC Proffered Paper Session II at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2021.

In this exploratory analysis, the median progression free survival (PFS) was 5.7 months (95% Confidence Interval, CI: 4.9, 7.6) and the median overall survival (OS) was 14.9 months (95% CI: 9.3, 21.1), with 56% and 32% of these patients alive at one year and two years, respectively. The objective response rate (ORR) was 18%, with 3% of patients achieving a complete response (CR) and 15% of patients achieving a partial response (PR). The median duration of response (DOR) was 12.8 months.

"As many as seventy percent of patients with non-small cell lung cancer have progression of their disease on or after receiving checkpoint inhibitor therapy, leaving these patients with a continued unmet medical need," said Dr. Ticiana Leal, M.D., lead study author, and faculty member at Emory University. "Targeting the TAM and VEGFR receptor tyrosine kinases has been shown to modulate the tumor microenvironment toward a less immunosuppressive state. The encouraging results presented today support combining sitravatinib with a checkpoint inhibitor to help augment the antitumor response."

The sitravatinib and nivolumab combination in this analysis was well-tolerated and consistent with what has been previously reported for this regimen in patients with non-squamous NSCLC who are CPI experienced. Grade 3/4 treatment-related adverse events (TRAEs) were reported in 66% of patients. The rate of TRAEs leading to study treatment discontinuation was 22%.

"These data reinforce the scientific rationale to combine sitravatinib with nivolumab, which in this analysis, resulted in extending overall survival in patients with non-squamous non-small cell lung cancer, or NSCLC, and compares favorably to historical results with the standard of care, docetaxel," said Charles M. Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "The exploratory Phase 2 results support our ongoing Phase 3 SAPPHIRE study, which is evaluating this same regimen in patients with second or third line NSCLC who are resistant to immune checkpoint inhibitor therapy, and is expected to have an interim overall survival readout in the second half of 2022."

Virtual Investor Event

Mirati Therapeutics will host a virtual Investor Event on Monday, September 20, 2021 at 8:30 a.m. ET / 5:30 a.m. PT.

Company executives will discuss:

A top-line update from the Phase 2 registrational cohort of the KRYSTAL-1 study evaluating adagrasib in previously-treated patients with KRASG12C-mutated NSCLC
Findings from the colorectal cancer (CRC) cohort of the Phase 1/2 KRYSTAL-1 study evaluating adagrasib as monotherapy and in combination with cetuximab in patients with heavily pretreated CRC harboring the KRASG12C mutation, as presented at the 2021 ESMO (Free ESMO Whitepaper) Congress
Results from the Phase 2 MRTX-500 study evaluating sitravatinib combined with nivolumab in patients with non-squamous NSCLC who progressed on or after prior checkpoint inhibitor therapy, as presented at the 2021 ESMO (Free ESMO Whitepaper) Congress
Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

About MRTX-500

MRTX-500 (NCT02954991) is an open-label, parallel Phase 2 study evaluating the tolerability and clinical activity of sitravatinib in combination with nivolumab in patients with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who have experienced progression of disease on or after treatment with a checkpoint inhibitor (CPI). Patients received oral sitravatinib once daily (QD) in combination with nivolumab 240/480 mg intravenously every 2/4 weeks, as continuous 28 day cycles. The primary endpoint was objective response rate as defined by RECIST 1.1. Secondary endpoints included safety, tolerability, duration of response, progression free survival, and overall survival.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are resistant to prior immune checkpoint inhibitor therapy and progressed on platinum doublet therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combinations with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib in combination with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

For more information visit Mirati.com/science.

On September 20, 2021 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and ADC-based therapies, reported that it has received another milestone payment from Boehringer Ingelheim (BI) for the progress of a second oncology drug candidate (BI 765049), discovered during the first phase of the partnership, into the clinic (Press release, Oxford BioTherapeutics, SEP 20, 2021, View Source [SID1234588060]). In addition to OBT’s clinical asset, OBT076, this BI drug candidate is one of OBT’s several existing immuno-oncology programs that have been enabled through OGAP.

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In this Phase 1 clinical trial, BI 765049, will be administered to patients with advanced solid tumours including colorectal cancer, gastric carcinoma, pancreatic carcinoma, non-small cell lung cancer, hepatocellular carcinoma, and head and neck squamous cell carcinoma.

"The advancement of the second oncology drug candidate, developed under our collaboration with BI, into the clinic is a major validation of our proprietary OGAP drug discovery platform", said OBT’s Chief Executive Officer, Dr. Christian Rohlff. "Selecting the right target is fundamental for the successful development of a first-in-class antibody drug product. OBT’s platforms are designed to discover and engineer antibody constructs to novel therapeutic targets – these include bi-specific, Chimeric Antigen Receptor T Cell (CAR-T), Antibody Drug Conjugate (ADC) and Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) therapeutics – to best address difficult-to-treat cancers. We believe that the advancement of the first two BI compounds, directed to an oncology target identified by us, into the clinic, further validates our approach".

"We look forward to applying our experience to the continued advancement of our partnered and in-house programs, including our most advanced asset, OBT076, a CD205 targeting antibody, which is successfully progressing through dose escalation in the U.S. for patients with high risk breast cancer and other solid tumors", commented Abderrahim (Rahim) Fandi, M.D., Ph. D, Chief Medical Officer of OBT. "Our U.S. clinical program is truly innovative because OBT076 not only acts to destroy tumor cells directly but can also potentially reverse immune tolerance. By targeting chemotherapy failure, in CD205 positive solid tumour patients, our strategy represents a new treatment approach for these patients with limited existing treatment options and rapid disease progression."

On September 20, 2021 PharmaMar (MSE:PHM) reported that new data on Yondelis (trabectedin) in patients with metastatic or inoperable leiomyosarcoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, which is being held virtually from 16th to 21st September (Press release, PharmaMar, SEP 20, 2021, View Source [SID1234596669]).

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Under the title "LMS-04 study: a randomised, multicenter phase-III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in nonprogressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma. A French Sarcoma Group study," the French Sarcoma Group will present data from a phase III study comparing first-line treatment with trabectedin in combination with doxorubicin versus standard-o-care single-agent doxorubicin for the first-line treatment of patients with metastatic or unresectable leiomyosarcoma.

The study achieved its primary endpoint of Progression Free Survival (PFS), progression RECIST (Response Evaluation Criteria In Solid Tumors)1 , supplemented by central review. In the combination arm of trabectedin with doxorubicin, median PFS reached 12.2 months, compared to 6.2 months with single-agent doxorubicin (HR = 0.41; 95% CI 0.29-0.58; P<0.0001).

In addition, the Overall Response Rate (ORR) was 38% using the combination, compared to 13% in the comparator arm. Overall Survival (OS) was 30.5 months in patients who received trabectedin in combination with doxorubicin, compared to 24.1 months in patients who received doxorubicin alone.

Patricia Pautier, M.D., oncologist, head of the multidisciplinary committee of gynecologic oncology at Gustave-Roussy and lead author of the study, said: "Leiomyosarcoma has been classically reported as the most frequent soft tissue sarcoma subtype together with liposarcoma, a third of them have a uterine location. Patients have a poor prognosis when leiomyosarcomas are metastatic. In prospective clinical trials, a median PFS of about 6 months and overall survival of around 12–15 months are usually reported for patients treated with any first-line chemotherapy, representing a true unmet medical need. In general, Doxorubicin and Ifosfamide are the backbone of sarcoma treatment, but nor other association nor new therapies are superior to doxorubicin in terms of overall survival." She added: "Trabectedin is known to be active in second line treatment for leiomyosarcomas.

The previous phase II of the trabectedin-doxorubicin combination in metastatic or advanced LMS in first line therapy (LMS02) share very encouraging results in terms of ORR, PFS and OS. The results of the LMS04 study have confirmed that this combination is superior in terms of PFS to doxorubicin alone with a 6 months statistical benefit; the impact on PFS2 also is in favor of the use of the association in combination rather than in a sequential way. There is a clinical impact on overall survival and a longer follow-up will let us know if this therapy will impact overall survival and will be the new standard of treatment in this indication.

On September 20, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC) (Press release, AVEO, SEP 20, 2021, View Source [SID1234587956]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

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"The FDA’s decision to grant FTD underscores the potential for ficlatuzumab to address a serious unmet need and serve as a meaningful therapeutic option for patients with metastatic HNSCC," said Michael Bailey, president and chief executive officer of AVEO. "We are committed to unlocking the full potential of ficlatuzumab in patients with HNSCC and look forward to working closely with the FDA to determine next steps for the program."

In June 2021, the Company announced positive results from a randomized confirmatory Phase 2 study of ficlatuzumab, AVEO’s hepatocyte growth factor (HGF) targeted antibody, alone or in combination with cetuximab, an EGFR-targeted antibody, in patients with metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory). Of note, patients with HPV negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated both a superior overall response rate and median progression free survival. A copy of the presentation is available at www.aveooncology.com.

As previously disclosed, a shortage of required key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing has delayed the delivery of the clinical supply of ficlatuzumab. The Company anticipates the potential start date for a registrational study in HPV negative HNSCC will be in 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is an investigational potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC).