On December 16, 2021 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported an update from the ongoing Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT) (Press release, In8bio, DEC 16, 2021, View Source [SID1234597303]). The three patients with relapsed acute myeloid leukemia (AML) treated to date demonstrate that allogeneic gamma-delta T cell therapy has a manageable toxicity profile with the potential for durable responses in high-risk patients. Haploidentical HSCT patients have high relapse rates of up to 50% at one-year post-treatment. All three of the INB-100 treated patients remain in remission with two patients in remission at 18 and 20 months, respectively. No treatment-related grade 3 or greater adverse events, infusion reactions or dose-limiting toxicities were observed. The trial continues to track these patients and enroll additional patients.

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"We believe that the encouraging early data from the first patients dosed in this clinical trial suggest the potential of gamma-delta T cells to offer a novel treatment option for patients with aggressive hematologic malignancies," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "Multiple complete responses with durability greater than 1.5 years is especially promising for patients with high-risk leukemias, who have high rates of post-HSCT relapse. The absence of grade 3 or greater graft versus host disease (GvHD) 100 days post gamma-delta T cell infusion is also encouraging for an allogeneic therapy. We continue to enroll patients in this Phase 1 clinical trial and look forward to reporting additional data from this program in 2022."

This Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic, or donor-derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date, including patients with trisomy 8, del7 mutations. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.

The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.

On December 16, 2021 City of Hope doctors reported that data on an investigational bispecific antibody for multiple myeloma and the CMVPepVax, a City of Hope-developed vaccine against the cytomegalovirus, at this year’s ASH (Free ASH Whitepaper) Annual Meeting (Press release, City of Hope, DEC 16, 2021, https://www.businesswire.com/news/home/20211216005412/en/City-of-Hope-presents-leading-edge-research-on-blood-cancer-therapies-and-its-vaccine-to-reduce-stem-cell-transplant-complications-at-American-Society-of-Hematology-ASH-Annual-Meeting [SID1234597335]).

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"City of Hope continues to be a leader in innovative research on investigational immunotherapies for blood cancers and improving stem cell transplants," said Eileen Smith, M.D., City of Hope’s Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation. "New research at this year’s ASH (Free ASH Whitepaper) conference includes promising investigational immunotherapies for lymphoma, multiple myeloma, leukemia and other blood cancers and an update on a City of Hope-developed vaccine to prevent a virus that can cause serious complications in stem cell transplant recipients."

Here are highlights of City of Hope research presented at the ASH (Free ASH Whitepaper) conference:

Investigational bispecific antibody for multiple myeloma is well-tolerated and effective

Bispecific antibodies are an emerging immunotherapy against blood cancers. City of Hope’s Elizabeth Budde, M.D., Ph.D., presented at this year’s ASH (Free ASH Whitepaper) conference on mosunetuzumab. The research demonstrated that mosunetuzumab is a safe and effective investigational bispecific antibody for follicular lymphoma.

Talquetamab is an investigational therapy that is also demonstrating encouraging results for the treatment of relapsed multiple myeloma, according to a study led by Amrita Krishnan, M.D., director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at City of Hope and chief, Division of Multiple Myeloma.

Talquetamab targets the G protein-coupled receptor family C group 5 member (GPRC5D) that has a high expression on malignant plasma cells and is limited on normal human tissue. The first-in-class bispecific antibody directs T cells to kill multiple myeloma cells by binding to both GPRC5D and CD3 receptors.

Patients with relapsed or difficult to treat multiple myeloma in the Phase 1 study received recommended Phase 2 doses as an injection on a weekly or biweekly basis. By increasing the doses slowly, researchers hope that will help to minimize the severity of cytokine release syndrome.

Krishnan presented data on 55 patients. For the study, 30 patients who received the therapy weekly (and their results were evaluable, meaning they could be included in the study) and 23 people who received it on a biweekly schedule were included. The study is ongoing.

In the weekly cohort, the overall response rate was 70% and there was a very good partial response or better in 57% of patients.

"The response numbers are very strong and what’s also remarkable is that the responses were durable and deepened over time in both groups," Krishnan said.

Cytokine release syndrome occurred in 73% of the weekly dose cohort, but only one patient had a severe case and it was treatable. Other side effects included neutropenia and dysgeusia.

"We are excited that our results demonstrated that talquetamab is well-tolerated and highly effective at the Phase 2 dose level and with tolerable side effects," Krishnan said.

Further studies of the therapy on its own or in combination with other treatments for multiple myeloma are underway.

City of Hope-developed vaccine to prevent cytomegalovirus shows safety, tolerability

Despite therapies to help prevent the cytomegalovirus (CMV), which can flare up in blood marrow/stem cell transplant recipients who are immunocompromised, CMV infections are one of the most common complications in these patients. Furthermore, the antiviral drugs used to prevent flare-ups are toxic, expensive and increase the risk of other opportunistic infections.

City of Hope has developed an anti-CMV vaccine, known as CMVPepVax. At this year’s ASH (Free ASH Whitepaper) conference, the results of a Phase 2 trial using CMVPepVax were reported by Ryotaro Nakamura, M.D., City of Hope’s Jan & Mace Siegel Professor in Hematology & Hematopoietic Cell Transplantation in the Division of Leukemia.

The double blinded, placebo-controlled, randomized Phase 2 trial enrolled stem cell transplant recipients from four transplant centers, including City of Hope. Nakamura reported on data from 32 patients in the vaccine arm and 29 patients in the placebo arm.

CMVPepVax was delivered via injections 28 days after transplant and 56 days after the procedure.

Trial results demonstrated that there was no difference in CMV reactivation in both arms.

CMVPepVax was well-tolerated in patients with no increase in adverse side effects. Transplant outcomes were also similar between the two groups when comparing one-year overall survival, relapse-free survival, nonrelapse mortality, relapse and acute graft-versus-host disease (GVHD).

Significantly higher levels of CMV-targeting T cells were measured in patients in the vaccine arm who did not have CMV in their bloodstream. In patients who had the CMVPepVax injections, robust expansion of functional T cells also occurred.

"Our results confirm that CMVPepVax is safe to use and provides an immune response," Nakamura said. "Although the vaccine did not reduce the presence of CMV in the bloodstream, there were favorable CD8 T cell responses, which are protective in principle, but maybe didn’t recover fast enough to prevent CMV from reactivating."

Next steps include researching whether stem cell donors who receive the vaccine can transfer immunity to patients, as well as providing a booster to patients. This may lead to faster immune responses after transplant.

Using probiotics for stem cell transplant patients

City of Hope is a leader in bone marrow and stem cell transplantation — it was one of the first cancer centers nationwide to perform a bone marrow transplant and has performed more than 17,000 bone marrow/stem cell transplants since 1976. Because of this leadership, City of Hope doctors and scientists are investigating how to make the transplant process better, as well as how to deal with complications that may arise from the procedure, such as GVHD.

Led by Karamjeet S. Sandhu, M.D., an assistant professor in City of Hope’s Division of Leukemia in the Department of Hematology & Hematopoietic Cell Transplantation, a City of Hope study examined how adding the probiotic CBM 588 to transplant recipients’ diets might decrease inflammation in the gut and lower the risk of GVHD. The results were discussed in an oral presentation at the ASH (Free ASH Whitepaper) conference.

Sandhu explained that the body hosts microbial communities, known as the microbiome. These microbes help the body in several metabolic processes, such as digesting food, strengthening the immune system, protecting against other bacteria and producing vitamins, including B vitamins.

Recent studies have shown the microbiome can play a role in cancer risk and how a person’s body responds to cancer treatment. In people with blood cancers who receive a transplant, there is a direct link between the health of microbiome and survival.

"Imbalance among these microbial species have also been associated with several transplant complications including GVHD," said Sandhu, M.D. He added that the imbalance also contributes to morbidity and mortality.

For the study, Sandhu and his team used Clostridium Butyricum Miyairi 588 (CBM588), a probiotic strain that has been used in Japan for several decades to manage diarrhea caused by antibiotics or infections. CBM588 is a butyrate-producing bacteria present in the spore form in soil and food. Administration of CBM588 has shown anti-inflammatory and immune modulating effects, as well as evidence of anti-cancer activity.

This was the first study of CBM588 among bone marrow/stem cell transplant recipients. Fifteen patients received the current standard of care therapies to prevent GVHD and 21 received CBM588 in addition to standard of care for GVHD.

"Our study demonstrated that CMB588 is safe and feasible to use in this patient population without increasing mortality," Sandhu said. "We even noted an improvement in gastrointestinal GVHD, but further studies are needed to prove the effect and mechanism of action among recipients of bone marrow/stem cell transplantation."

Joint study examines somatic mutations in CMML patients, impact on stem cell transplants

Chronic myelomonocytic leukemia (CMML) is a rare form of leukemia that primarily affects older adults. The only potential cure at this time is allogeneic hematopoietic cell transplantation, also known as a stem cell transplant.

Research has shown that somatic mutations — genetic changes that are acquired during life and not inherited — are an important factor in determining prognosis for CMML patients. However, limited data are available regarding their impact on outcomes after CMML patients receive transplant.

A joint study between City of Hope and Center for International Blood and Marrow Transplant Research (CIBMTR) analyzed the relationship between somatic mutations in CMML and their impact on stem cell transplants.

Additionally, the study aimed to evaluate two separate scoring systems commonly used in nontransplant CMML patients, the CMML-specific prognostic scoring system (CPSS) and molecular CPSS (CPSS-Mol), which takes into account the somatic mutations, to find out if they can predict the results of a transplant.

Led by City of Hope’s Matthew Mei, M.D., an associate professor in City of Hope’s Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, the study included 313 patients across 78 different transplant centers, all of whom underwent a comprehensive mutation analysis of 131 genes performed at City of Hope under the supervision of Raju K. Pillai, M.D., director of Pathology Core Laboratories in Beckman Research Institute of City of Hope.

The study found that 93% of patients had at least one mutation identified, and the median number of mutations was three. The most frequently mutated genes were ASXL1 (62%), TET2 (35%), KRAS/NRAS (33% combined) and SRSF2 (31%); TP53 was mutated in 3% of patients.

Both the CPSS and CPSS-Mol were predictive of overall survival after transplant; however, neither system was able to identify patients who were at an increased risk of relapse. Furthermore, the incorporation of somatic mutations did not appear to refine the prognosis.

"Our study is the largest analysis of CMML patients who underwent a stem cell transplant with paired mutation analysis," Mei said. "Overall, patients with CMML remain at high risk for relapse after transplant. Novel therapies aimed at decreasing relapse and making transplants safer, as well as improved methods of predicting outcomes of transplant in CMML, are still critically needed."

Additional research on chimeric antigen receptor (CAR) T therapy and stem cell transplantation presented at ASH (Free ASH Whitepaper)

Tanya Siddiqi, M.D., director of City of Hope’s Chronic Lymphocytic Leukemia Program, also presented a poster on the Transcend NHL 001 trial at the ASH (Free ASH Whitepaper) conference, and Ibrahim Aldoss, M.D., associate professor, City of Hope’s Division of Leukemia, presented a poster on the outcomes of allogeneic hematopoietic cell transplantation in adults with Ph-like acute lymphoblastic leukemia.

City of Hope is a leader in blood cancer research and treatment. The National Cancer Institute-designated comprehensive cancer center has performed more than 17,000 bone marrow/stem cell transplants and is a leader in chimeric antigen receptor (CAR) T therapy, with nearly 800 patients treated with immune effector cells, including CAR T therapy, and nearly 80 open or completed trials.

On December 16, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in a Phase 1/2 clinical trial (NCT05086315), evaluating IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS) (Press release, Innate Pharma, DEC 16, 2021, View Source [SID1234597280]).

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The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various CD123-expressing hematological malignancies.

This trial is supported by positive pre-clinical results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Congress, which demonstrated the CD123-targeted molecule’s potent antitumor activity against AML, including evidence supporting greater anti-leukemia activity compared with an anti-CD123 antibody. IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.

"We’re pleased with the initiation of the clinical trial for IPH6101/SAR443579, which is the first ANKETTM asset to enter the clinic. ANKETTM is our new multi-specific NK cell engager platform, which has the potential to engage NK cells through NKp46 and CD16, and more broadly, generate an entirely new class of molecules to induce synthetic immunity against cancer," said Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer of Innate Pharma. "We look forward to continuing to advance this platform given the critical role NK cells play in the cancer immunity cycle."

The start of the trial has triggered a milestone payment from Sanofi to Innate, which is part of a previously announced research collaboration with Sanofi. Under the agreement, the companies collaborate on the generation and evaluation of up to two bispecific ANKETs, using technology from Innate and Sanofi’s proprietary bispecific antibody formats as well as tumor targets. The companies are currently working on the second research program under the agreement.

More information about the Phase 1/2 trial can be found here.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKETTM molecule, is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a tumor antigen and the interleukin-2 receptor (by an IL-2 variant, IL-2v), via a single molecule. This molecule leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In pre-clinical studies, Innate’s tri-1 and tetra-specific ANKETTM technologies promote potent NK cell activation, cytotoxicity and efficient control of tumor growth in pre-clinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6101/SAR443579:

In the first research program of the Sanofi collaboration, IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format, has shown antitumor activity in pre-clinical models, including supportive pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies leading to its selection as a drug candidate for development.

About the Innate-Sanofi agreement:

The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

On December 16, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that it has been selected for addition to the NASDAQ Biotechnology Index ("NBI") (Press release, Kinnate Biopharma, DEC 16, 2021, View Source [SID1234597304]). Kinnate’s addition to the NBI will become effective prior to market open on Monday, December 20, 2021.

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The NBI is designed to track the performance of a set of securities listed on The NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical companies, and is a modified market capitalization weighted index. The NBI is reconstituted annually in December in accordance with a set of eligibility criteria including minimum market capitalization and average daily trading volume, among other criteria.

"We are pleased to be added to the NASDAQ Biotechnology Index and see it as reflection of the progress we have made this year," said Nima Farzan, Chief Executive Officer of Kinnate. "2021 has been transformative for Kinnate and the inclusion in this index will enable greater awareness about Kinnate’s mission and pipeline."

On December 16, 2021 Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that YESCARTA (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo (Press release, Kite Pharma, DEC 16, 2021, https://www.businesswire.com/news/home/20211216006041/en/Daiichi-Sankyo-Authorizes-the-First-YESCARTA%C2%AE-Axicabtagene-Ciloleucel-CAR-T-cell-Therapy-Treatment-Site-in-Japan [SID1234597338]). Kite and Daiichi Sankyo will also build on the exclusive licensing deal for commercialization rights for axicabtagene ciloleucel in Japan, formalized in January 2017. Both partners are pleased to agree on a broadening of their business collaboration in Japan.

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"We are pleased to bring the benefits of axicabtagene ciloleucel to eligible patients in Japan, in collaboration with Daiichi Sankyo," said Warner Biddle, Kite’s Global Head of Commercial. "Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally1 and we remain committed to bringing our innovative CAR T-cell therapies to additional new markets."

"We are pleased to be able to deliver axicabtagene ciloleucel, Daiichi Sankyo’s first cell therapy product, to patients in Japan," said Akio Sakurai, Daiichi Sankyo Corporate Officer, Head of Sales Division. "By strengthening our collaboration with Kite, the originator of axicabtagene ciloleucel and a world leader in cell therapy, we will strive to bring this innovative therapy to as many patients as possible."

CAR T-cell therapy is a complex immunotherapy, and all hospitals must complete a rigorous training process before administering axicabtagene ciloleucel to patients. These hospitals receive specific training in handling and risk minimization procedures in order to ensure that patient safety remains a priority.

Several factors are considered when qualifying a hospital, including their specialist skills and services, geographic coverage and experience in managing other complex procedures, such as stem cell transplantation and a co-located intensive care unit.

Axicabtagene ciloleucel has been approved in Japan for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The use of axicabtagene ciloleucel is limited to patients not previously treated with a CD-19 CAR-positive T-cell infusion; patients previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant; and, patients ineligible for an autologous stem cell transplant. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company.

The approval of axicabtagene ciloleucel in Japan is based on data from the global pivotal trial conducted by Kite (ZUMA-1)2 and results of a Phase 2 study conducted by Daiichi Sankyo in Japan. In the Japanese Phase 2, open-label, single-arm study, the same dose (2.0 x 106 cells/kg) of axicabtagene ciloleucel as used in the ZUMA-1 study was administered to assess efficacy and safety in 16 Japanese patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The study reached its primary endpoint, demonstrating an objective response rate (ORR) of 86.7% (95% CI: 59.5 – 98.3%).

The overall safety and tolerability profile of axicabtagene ciloleucel in the Japan trial was consistent with that observed in ZUMA-1. Dose limiting toxicity was not observed. Grade ≥3 treatment emergent adverse event occurred in all patients; most commonly neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%). Cytokine release syndrome (CRS), a typical CAR T-cell therapy-emergent adverse event, occurred in 13 patients (81.3%, all Grade), with Grade ≥3 CRS in one patient (6.3%). No neurological events, another CAR T-cell therapy-emergent adverse event, were observed.

About YESCARTA

YESCARTA (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient’s T cells and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells. The CAR T therapy is manufactured specifically for each patient and administered only once.3

Axicabtagene ciloleucel received Orphan Drug Designation from the Japan MHLW in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma.

YESCARTA is approved in the U.S. and Europe for patients with certain types of relapsed or refractory B-cell lymphoma, where it is developed, manufactured and commercialized by Kite.

Please see full U.S. Prescribing Information, including BOXED WARNING and Medication Guide.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).