On May 31, 2019 NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell based therapeutics company, NantCell Inc., a privately held immunotherapy company, and NantOmics, a privately held molecular diagnostic company, reported that preclinical and clinical updates will be provided in four abstracts as part of the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL, which runs from May 31st – June 4th, 2019 (Press release, NantKwest, MAY 31, 2019, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-nantcell-and-nantomics-provide-updated-preclinical-and?field_nir_news_date_value[min]=2019 [SID1234536734]).

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Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest, NantCell and NantOmics, commented, "Through a unique collaboration, combining the expertise of NantOmics’ multi-omics diagnostic capabilities with NantKwest’s and NantCell’s therapeutic capabilities, we are pleased to report for the first time the ability to comprehensively analyze a patient’s circulating cell-free RNA (cfRNA) and T Cell Receptor (TCR) repertoire and therapeutically intervene across a range of tumor types. We believe this type of fully integrated diagnostic and therapeutic intervention represent the next-generation in cancer care and shows real promise in improving response rates in comparison to traditionally single agent approaches. We look forward to transitioning these advances in medicine to the clinical care setting as quickly as possible."

Abstract Title: Innate and adaptive immunotherapy: An orchestration of immunogenic cell death by overcoming immune suppression and activating NK and T-cell therapy in patients with third line or greater Triple-Negative Breast Cancer (TNBC).

Sub-category: Triple-Negative

Category: Breast Cancer—Metastatic

Meeting: 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Number: e12566

Citation: J Clin Oncol 37, 2019 (suppl; abstr e12566)

Author(s):Chaitali Singh Nangia, Mira Kistler, Leonard S. Sender, John H. Lee, Frank R. Jones, Omid Jafari, Patrick Soon-Shiong; Chan Soon Shiong Institute for Medicine, Laguna Hills, CA; Chan Soon Shiong Institute of Medicine, El Segundo, CA; Children’s Hospital of Orange County, Laguna Hills, CA; Sanford Health, Sioux Falls, SD; Etubics Corporation, Seattle, WA; Medical Imaging Center of Southern California, Santa Monica, CA; NantKwest, Culver City, CA

Summary: Triple-negative breast cancer (TNBC) is a heterogenous subtype of breast cancer that is frequently aggressive and has limited treatment options. We hypothesize that effective and sustained response against TNBC requires a coordinated approach that: (1) reverses the immune-suppressive tumor microenvironment, (2) induces immunogenic tumor cell death and (3) Re-engages NK and T-cell tumor response against a cascade of tumor antigens. To test this hypothesis, we have developed a temporospatial approach that combines metronomic low dose chemotherapy, SBRT, off-the-shelf cryopreserved allogeneic NK cells, yeast and adenoviral tumor-associated antigen vaccines, an IL-15RαFc superagonist, and checkpoint inhibition. Methods: A phase 1b trial in patients with previously-treated metastatic TNBC was initiated. Treatment occurred in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), SBRT, engineered allogeneic CD16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA, MUC1, brachyury, and HER2 vaccines, yeast vector-based Ras, brachyury and CEA vaccines, and an IgG1 PD-L1 inhibitor, avelumab. The primary endpoint is incidence of treatment-related adverse events (TRAEs). Secondary endpoints include ORR, DCR, PFS, and OS. Preliminary results reported on 8 subjects treated with 3rd-line or greater TNBC that have received at least 3 treatment cycles (mean = 6 cycles). All treatment was administered in an outpatient setting. All subjects had at least 1 grade ≥3 TRAE, primarily chemotherapy-related neutropenia. Grade ≥3 haNK-related AEs (fever and fatigue) were observed in 2 subjects. 2 subjects experienced SAEs. 7 subjects remain alive, with 6 subjects receiving ongoing study treatment. 1 CR (confirmed) and 2 PRs (one confirmed) have been observed to date. These preliminary data suggest that low-dose chemo-radiation combined with innate and adaptive immunotherapy can be administered safely in an outpatient setting with a manageable safety profile. Clinical trial information: NCT03387085.

Abstract Title: Innate and adaptive immunotherapy: An orchestration of immunogenic cell death by overcoming immune suppression and activating NK and T cell therapy in patients with third line or greater metastatic pancreatic cancer.

Sub-category: Pancreatic Cancer

Category: Gastrointestinal (Noncolorectal) Cancer

Meeting: 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Number: e15787

Citation: J Clin Oncol 37, 2019 (suppl; abstr e15787)

Author(s): Tara Elisabeth Seery, Mira Kistler, Leonard S. Sender, John H. Lee, Arvind Manohar Shinde, Anand Annamalai, Patrick Soon-Shiong; Chan Soon Shiong Institute for Medicine, Laguna Hills, CA; Chan Soon Shiong Institute of Medicine, El Segundo, CA; Chan Soon Shiong Institute for Medicine, El Segundo, CA; NantKwest, Culver City, CA; St. Vincent Medical Center, Los Angeles, CA; St. Vincent’s Medical Center, Los Angeles, CA

Summary:

Pancreatic cancer has multiple mechanisms to prevent immune recognition that lead to the creation of an immune suppressive tumor microenvironment. Our hypothesis is that sustained response against pancreatic cancer requires a coordinated approach that: (1) reverses the immune-suppressive tumor microenvironment, 2. induces immunogenic tumor cell death and (3) re-engages NK and T-cell tumor response against a cascade of tumor antigens. To test this hypothesis, we have developed a temporospatial approach that combines metronomic low-dose chemotherapy, SBRT, cryopreserved allogeneic NK cells, yeast and adenoviral tumor-associated antigen vaccines, an IL-15RαFc superagonist, and checkpoint inhibition. These preliminary data suggest that low-dose chemo-radiation combined with innate and adaptive immunotherapy can be administered safely in an outpatient setting.

Preliminary results of 12 subjects treated with 3rd-line or greater metastatic pancreatic cancer. All treatment was administered in an outpatient setting. AEs were primarily hematologic and managed by planned chemo dose reduction. Grade ≥3 TRAEs were observed in 9 out of 12 subjects, predominately chemotherapy-related neutropenia. 9 out of 12 subjects (75%) had a best response of stable disease (≥ 8 weeks). Median PFS is 7.1 months (4.4 – 8.8) and median OS is 8.2 months (5.7 – 9.7) with 1 subject continuing treatment

Preliminary Overall Survival of 8.2 months is encouraging for this heavily-pretreated population. Clinical trial information: NCT03586869.

Abstract Title: Correlation between circulating cell-free RNA biomarkers and response during combination immunotherapy in previously refractory metastatic TNBC patients.

Sub-category: Circulating Biomarkers

Category: Developmental Immunotherapy and Tumor Immunobiology

Meeting: 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract No: e14027

Citation: J Clin Oncol 37, 2019 (suppl; abstr e14027)

Author(s):Chad Garner, Tara Elisabeth Seery, Chaitali Singh Nangia, John H. Lee, Liyang Huang, Leonard S. Sender, Shahrooz Rabizadeh, Patrick Soon-Shiong; NantHealth, Culver City, CA; Chan Soon Shiong Institute for Medicine, Laguna Hills, CA; NantKwest, Culver City, CA; Chan Soon-Shiong Institute for Medicine, El Segundo, CA; NantOmics, LLC, Culver City, CA; CSS Institute of Molecular Medicine, Culver City, CA.

Summary: A commercial liquid biopsy test was included as an exploratory component of an integrated immunotherapy clinical trial in previously refractory metastatic TNBC patients, combining innate, high-affinity natural killer cell (haNK) therapy with adenoviral and yeast-based vaccines and an IL-15 superagonist (NCT 03387085). The purpose of the study was to assess the utility of cell-free circulating RNA (cfRNA) as a predictor of treatment response. The amount and variability of cfRNA was found to be positively correlated with the tumor size. As cfRNA quantity and variability increased or decreased, a corresponding increase or decrease in tumor size was observed, respectively. Not all 18 genes showed consistent patterns of change across the six patients, however the average expression and variability of the 18 genes showed evidence of a correlation with tumor size change from baseline (p-values = 0.08 and 0.03, respectively). Only trace levels of PD-L1 expression were observed in all 6 patients at baseline, prior to the initiation of the combination immunotherapy. Among the 5 patients that showed a reduction in tumor size of at least 10%, 4 also showed an associated increase in cfRNA PD-L1 expression from nearly 0 to normalized values between 2.1 and 6.8. In an exploratory analysis in an ongoing combination immunotherapy clinical trial for TNBC showed that increasing and decreasing cfRNA levels are correlated with increasing and decreasing tumor size, respectively. Increased PD-L1 cfRNA levels are correlated with beneficial treatment response. Liquid biopsy of cfRNA could provide an effective biomarker of treatment response. Clinical trial information: NCT03387085.

Abstract Title: TCR repertoire analysis from peripheral blood for prognostic assessment of patients during treatment

Sub-category: Circulating Biomarkers

Category: Developmental Immunotherapy and Tumor Immunobiology

Meeting: 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Number: e14040

Citation:J Clin Oncol 37, 2019 (suppl; abstr e14040)

Author(s): Sadanand Vodala, Andrew Nguyen, Noe Rodriguez, Peter Sieling, Charles Joseph Vaske, Jon Van Lew, Kayvan Niazi, John H. Lee, Patrick Soon-Shiong, Shahrooz Rabizadeh; NantOmics, LLC, Culver City, CA; NantOmics, LLC, Santa Cruz, CA; NantBio, Inc, Culver City, CA; Sanford Health, Sioux Falls, SD; NantKwest, Culver City, CA

Summary:

Immune checkpoint inhibitor therapy offers substantial clinical advantage to a subset of patients but predictive/novel prognostic indicators are still scarce. T cell receptors (TCRs) play a crucial role in adaptive immunity and anti-tumor immune responses. Net diversity of TCR repertoires are altered in patients receiving immune checkpoint inhibitors. To study the prognostic significance of T cell repertoires as a biomarker of immune responses in cancer patients, TCR repertoires were characterized from peripheral blood using high throughput sequencing. Patients that show positive response had TCR clones that were stable, which may indicate an existing immune related response towards their tumor. TCR-targeted therapy potentially allows these existing T-cells to overcome blockade by tumor cells. Patients showing poor response show a TCR repertoire that is constantly changing potentially indicating that the tumor cells are not eliciting a strong T cell specific response. Further functional studies of T cell populations are planned to expand our understanding of T cell based immune therapies.

For additional information, please visit www.nantkwest, www.nantcell.com, and www.nantomics.

On May 31, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, MAY 31, 2019, View Source [SID1234536730]):

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Shalini Sharp, the company’s Chief Financial Officer, will present at the Jefferies Healthcare Conference on Tuesday, June 4, 2019 at 8:00 a.m. ET in New York, NY.

Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer, President and Founder, will present at the Goldman Sachs 40TH Annual Global Healthcare Conference on Thursday, June 13, 2019 at 9:20 a.m. PT in Palos Verdes, CA.
The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On May 31, 2019 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, reported updated interim data from its ongoing Phase 1/2 TRIDENT-1 clinical study of lead drug candidate repotrectinib in ROS1-positive non-small cell lung cancer (NSCLC) patients (Press release, Turning Point Therapeutics, MAY 31, 2019, View Source [SID1234536729]).

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The results, which will be presented today during an oral session at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), demonstrate ongoing antitumor activity and a manageable safety profile across multiple dose cohorts in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients, including patients with intracranial disease.

"With additional follow up and new patients enrolled in the TRIDENT-1 study, repotrectinib continues to demonstrate promising efficacy and a safety profile consistent with a potential best-in-class ROS1 therapy for patients with advanced non-small cell lung cancer," said Dr. Byoung Chul Cho, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. "The ongoing Phase 1 data remain encouraging in both TKI-naïve patients with intracranial disease and patients pretreated with crizotinib — including those with difficult to treat solvent front mutations — where there are currently very few therapeutic options."

Dr. Cho is an investigator for the TRIDENT-1 study and will present the data today at the annual ASCO (Free ASCO Whitepaper) conference.

Repotrectinib is an investigational next-generation TKI designed to effectively target ROS1 and TRK A/B/C and systemically overcome resistant mutations that invariably result following treatment with other TKIs. ROS1 rearrangement is an oncogenic driver of tumors in up to 2.6 percent of U.S. advanced NSCLC patients.

As of the March 4, 2019 data cut-off, the interim Phase 1 data showed the following results.

Preliminary Safety Analysis (n=83):

A total of 83 (ROS1+, NTRK+ and ALK+) patients were treated with repotrectinib at dose levels from 40 mg daily (QD) to 200 mg twice daily (BID).
Repotrectinib was generally well tolerated, with the most frequent treatment emergent adverse events (TEAEs) being Grade 1 or 2. The TEAEs found in >25% of pts were dizziness (57%), dysgeusia (51%), dyspnea (30%), fatigue (30%), constipation (29%), paresthesia (29%), and anemia (28%). There were few Grade 3 treatment-related AEs (anemia (n=3); dizziness (n=2); and dyspnea, hypophosphatemia, hypoxia, pleural effusion, and weight increase (all n=1)), and no Grade 4 treatment-related AEs or cases of dizziness leading to treatment discontinuation.
No additional dose-limiting toxicities (DLTs) have occurred since the last data cut-off of Oct. 31, 2018. Prior DLTs included Grade 3 dyspnea/hypoxia (n=1), and Grade 2 (n=1) and Grade 3 (n=2) dizziness. Four total Grade 5 TEAEs (one of four determined to be possibly treatment related) have occurred, with one Grade 5 case of respiratory failure reported as related to disease progression since the last interim data update.
Preliminary Efficacy Analysis (n=33)

Within the ROS1+ NSCLC blinded independent central review (BICR) efficacy evaluable population (n=33), the median number of prior TKI therapies was one (range 0 to 3), the majority of which were crizotinib.
Forty-five percent of patients remained on treatment (15/33), with 12 of the 15 (80%) patients remaining on treatment for more than 12 months.
TKI-Naïve Efficacy Analysis

In TKI-naïve patients, overall response rate (ORR) by BICR was 82 percent (9/11). At a dose of 160 mg QD or above, the likely recommended Phase 2 dose, ORR by BICR remains at 83 percent, consistent with the prior update. Efficacy results are summarized in the following table:

Prior Interim Analysis by BICR
Oct. 31, 2018 Data cut-off Current Interim Analysis by BICR
March 4, 2019 Data cut-off
All ROS1 NSCLC (TKI
Naïve & Pretreated) N=28 N=33
TKI Naïve N=10 N=11
Median Follow up –
(Range) 16.4 months
(5.3-16.6+) 16.4 months
(3.5+-19.4+)
ORR (%)
(95% CI) 9/10 (90)
(56-100) 9/11 (82)
(48-98)
ORR at 160 mg QD or
above 5/6 (83) 5/6 (83)
Median Duration of
Response – Months
(Range) Not Reached
(5.5+-14.9+)
5 of 9 remain in cPR
(5.5+ to 14.9+ months) Not Reached
(5.6-17.7+)
5 of 9 remain in cPR (10.9+ to 17.7+ months)
Intracranial ORR n (%)
(95% CI) 3/3 (100)
(29-100) 3/3 (100)
(29-100)
All remain in cPR
Clinical Benefit Rate (%)
(95% CI) 10/10 (100)
(69-100) 11/11 (100)
(72-100)
TKI-Pretreated Efficacy Analysis

In TKI-pretreated patients, ORR by BICR improved from 28 percent in the prior data cut-off to 32 percent, and from 44 percent to 55 percent in patients pretreated with 1 TKI and dosed at 160 mg QD or above. Efficacy results are summarized in the following table:

Prior Interim Analysis by BICR
Oct. 31, 2018 Data cut-off Current Interim Analysis by BICR
March 4, 2019 Data cut-off
All ROS1 NSCLC (TKI Naïve
& Pretreated) N=28 N=33
TKI Pretreated N=18 N=22
Median Follow up –
(Range) 12.9 months
(0.6-14.5) 14.6 months
(1.4-16.6+)
ORR (%)
(95% CI) 5/18 (28)
(10-53) 7/22 (32)
(14-55)

O
R
R

1 prior TKI 5/15 (33) 7/18 (39)
1 prior TKI
160 mg QD or above 4/9 (44) 6/11 (55)
1 prior TKI
crizotinib only
160 mg QD or above 3/6 (50) 4/7 (57)
2 or more prior TKIs 0/3 (0) 0/4 (0)
Duration of Response –
Months
# still in response (+) 1 of 5 responders still in cPR at 1.9+ months 3 of 7 responders still in cPR at 1.0+ to 7.6+ months
ORR in G2032R Solvent
Front Mutations
(%) 1/4 (25) 2/5 (40)
Intracranial ORR n (%)
1 prior TKI 2/4 (50)
2/3 (67) 3/5 (60)
3/4 (75)
Clinical Benefit Rate (%)
(95% CI) 14/18 (78)
(52-94) 16/22 (73)
(50-89)
Five patients pretreated with crizotinib had a ROS1 G2032R solvent front mutation detected at baseline by plasma cfDNA or next-generation sequencing tests. All five patients had tumor regressions, including two confirmed partial responses (cPR) at the 160 mg QD dose level.

"Since first reporting preliminary TRIDENT-1 interim data for repotrectinib at the 2018 annual ASCO (Free ASCO Whitepaper) meeting, we are very pleased to see the results continue to strengthen with each subsequent data cut-off while maintaining a consistent safety profile in both TKI-naïve and TKI-pretreated ROS1+ NSCLC patients," said Athena Countouriotis, M.D., president and chief executive officer. "The current treatment options for patients with ROS1+ advanced non-small cell lung cancer are limited, particularly when resistance develops to other TKIs. We look forward to finalizing our recommended Phase 2 dose and beginning the registrational portion of TRIDENT-1 in the second half of this year."

Financial Update
The company separately filed its Form 10-Q today for the first quarter of 2019. Operating expenses during the first quarter were $14.1 million compared to $4.9 million in the first quarter of 2018. The $9.2 million increase was primarily due to increased personnel expenses and activities for the development of repotrectinib, TPX-0022 and TPX-0046. Net cash used in operating activities was $10.2 million, an increase from $5.4 million in the prior-year period.

Turning Point expects expenses will increase through the year as it plans to initiate up to four clinical trials in 2019 including: the Phase 2 TRIDENT-1 registrational study for repotrectinib; a Phase 1/2 study of repotrectinib in pediatric patients with advanced solid tumors with NTRK, ALK, or ROS1 alterations; a Phase 1 dose-finding study for TPX-0022, a novel MET, CSF1R and SRC inhibitor in patients with advanced solid tumors harboring genetic alterations in MET; and, pending completion of IND-enabling studies, a Phase 1 study of TPX-0046, a novel RET and SRC inhibitor in patients with advanced solid tumors with oncogenic RET genetic alterations.

Cash and cash equivalents at March 31 were $90 million. In addition, the company raised net proceeds of $175.2 million from its April 2019 initial public offering. The company projects its cash position will be sufficient to fund current operations into the second half of 2021.

On May 31, 2019 OncoArendi Therapeutics will present and promote its programs during the 2019 BIO International Convention in Philadelphia, USA, recognized as one of the world’s most important events in the biotechnology and pharmaceutical industry. Over 16,000 participants from 67 countries will attend the conference (Press release, OncoArendi Therapeutics, MAY 31, 2019, View Source [SID1234536728]).

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OncoArendi represented by: Marcin Szumowski, CEO, Nicolas Beuzen, Director of Business Development and Pawel Dobrzanski, Senior Scientific Director has over 40 formally accepted meetings, during which two of the Company’s most advanced assets will be presented:

OATD-01, a drug developed in inflammation-driven fibrotic diseases currently completing phase Ib of clinical development, as well as
OATD-02, an arginase inhibitor for cancer treatment, currently completing IND-enabling studies.
– During this event we will meet new prospects potentially interested in global or regional (i.e. Asian) rights, and continue ongoing discussions, initiated at previous events, some already under confidentiality agreements. At the same time scouting will be conducted to identify novel molecules that could complement our portfolio of early stage programs – says Marcin Szumowski, CEO OncoArendi Therapeutics.

– We are keeping our eye on the global biotechnology market that grows at an increasing pace. Many new innovative ideas appear in areas directly related to research projects currently pursued by OncoArendi. Inhibitors of deubiquitinases, a family of proteins representing potential targets in cancer therapy is just one example. These targets have been recently pursued by several mid-size biotech companies, confirming the attractiveness of these new molecular targets in treatment of various diseases.

On May 31, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updated data from studies of TIL therapy LN-145 in patients with advanced cervical cancer and TIL therapy lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 31, 2019, View Source;p=RssLanding&cat=news&id=2400232 [SID1234536727]). At 7.4-month median follow-up in the ongoing study of LN-145 in advanced cervical cancer, an 11 percent complete response rate (CR) was seen. Furthermore, the median duration of response (DOR) had not been reached. At 8.8-month median follow-up in the ongoing study of lifileucel in advanced melanoma, median duration of response had not been reached. Updated data from the ongoing innovaTIL-04 and innovaTIL-01 studies will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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"As we continue to observe the effects of Iovance TIL therapy, we have not yet reached a median DOR for our TIL product in either our melanoma or cervical trial," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We are also extremely encouraged to see CRs in our cervical cancer study as the study continues over time, demonstrating the potential for deep responses after one treatment. The same phenomenon was noted in our melanoma trial as well with two CRs now being reported at ASCO (Free ASCO Whitepaper) in a heavily pre-treated melanoma patient population."

"The duration of response of current second line treatments for advanced cervical cancer are in the range of three to five months and options are limited," commented Emese Zsiros, M.D., Ph.D., faculty researcher at the Department of Gynecologic Oncology of the Roswell Park Comprehensive Cancer Center and Iovance LN-145 study investigator. "The observation in the study of LN-145 that median DOR has not yet been reached at a median of 7.4 months following treatment provides evidence that this therapy could provide a clinically meaningful improvement over currently available options for patients with advanced cervical cancer."

As of May 14, 2019, data from the innovaTIL-04 study in 27 patients with recurrent, metastatic or persistent cervical cancer demonstrated an objective response rate of 44 percent (3 complete responses and 9 partial responses) and a disease control rate of 85 percent. At 7.4-month median follow-up, 10 patients maintained a response and the median DOR had not been reached (range 2.6+ to 9.2+ months). The mean patient age was 45 years and study participants had experienced a mean of 2.4 prior lines of therapy. Study data will be presented on Saturday, June 1 (Abstract #2538, Poster 182).

As of May 8, 2019, results from Cohort 2 in the ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2 complete responses and 23 partial responses) in 66 consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. The disease control rate was 80 percent. At 8.8-month median follow-up, median DOR had not been reached (range 1.4+ to 19.8+ months). Study data will be presented on Saturday, June 1 (Abstract #2518, Poster 162).