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ARTICLE COMPARING SURVIVAL OUTCOMES OF ISOLATED LIMB INFUSION VERSUS PV-10 FOR IN-TRANSIT MELANOMA PUBLISHED IN JOURNAL OF SURGICAL ONCOLOGY

On January 29, 2019 Provectus (OTCQB: PVCT) reported that the Journal of Surgical Oncology (JSO) has published results from an investigator-conceived and led, single-center study of in-transit melanoma (ITM) patients receiving either regionally-administered isolated limb infusion (ILI) or intratumoral (aka intralesional) PV-10 to assess and compare the effect of these treatments on survival (Press release, Provectus Biopharmaceuticals, JAN 29, 2019, View Source [SID1234532943]). The JSO article detailed the work of investigators at the Princess Alexandra Hospital (PAH) in Brisbane, Australia, where ILI represents the historical standard of care for ITM and PV-10 was used to treat ITM under expanded access. Intratumoral injection of PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1,2,3,4

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This article, entitled "Patients with in-transit melanoma metastases have comparable survival outcomes following isolated limb infusion or intralesional PV-10 – A propensity score matched, single center study," may be accessed via the JSO’s website at View Source

Key Results from the JSO Article:

Baseline and disease characteristics:

Patients matched for key covariates: age, gender, primary disease site, and Breslow thickness
ILI: 36 patients; 56% men; median age of 76.5 years (interquartile range 69-83); 100% Stage IIIB/IIIC
PV-10: 36 patients; 56% men; median age of 74.5 years (65-81); 89% Stage IIIB/IIIC (11% Stage IV)

Treatment response (patient-level best overall response):

ILI: 22% complete response and 50% overall response rate
PV-10: 25% complete response and 83% overall response rate

Survival outcomes:

ILI
progression-free survival (PFS): median of 5.0 months (interquartile range 2.7-10.7)
disease-free survival (DFS): median of 16.5 months (8.9-48.4)
overall survival (OS): median of 29.7 months (12.3-88.5)
melanoma-specific survival (MSS): median of 74.4 months (24.3-NA); 12‐, 24‐, 36‐, and 60‐month MSS rates of 85%, 75%, 60%, and 60%, respectively
PV-10
PFS: median of 3.9 months (9.6-47.9)
DFS: median of 14.1 months (4.5-20.9)
OS: median of 27.1 months (14.3-48.6)
MSS: median of 36.4 months (16.6-65.3); 12‐, 24‐, 36‐, and 60‐month MSS rates of 83%, 70%, 54%, and 36%, respectively
Differences in PFS, DFS, and MSS comparing ILI with PV‐10 were not statistically significant
Among the authors’ conclusions:

"Overall these results demonstrate that demographically similar patients with in-transit melanoma metastases treated with ILI or PV-10 have comparable long-term survival rates,"

"Propensity score matching is a useful statistical technique for examining relative treatment effects within complex patient groups, particularly when larger randomized controlled studies are impractical,"

"A complete response to either treatment was the only independent factor identified that significantly predicted long-term survival,"

"These findings suggest that both ILI and PV‐10 can be considered as a suitable standard of care," and

"These treatments are relevant and likely to remain of value in the near future, particularly for the treatment of symptomatic or refractory metastases following the discontinuation of systemic therapies due to serious drug-related side-effects or exhaustion of other systemic options."
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Despite the advances made by targeted therapies and checkpoint inhibitors, these comparative survival data highlight the important role that investigational PV-10 may have for the treatment of advanced melanoma. The Australian investigators place PV-10’s role in the context of relatively more expensive systemic agents that have substantial toxicity profiles and similar response rates."

Mr. Rodrigues added, "Furthermore, these comparative survival data substantiate the Company’s historical work in melanoma and provide more validation of PV-10 in a single-agent setting for a challenging patient population. The key focus of Provectus’ drug development program now is to demonstrate PV-10 activity in both single-agent and combination therapy settings for the treatment of both hot and cold tumor types."

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results

On January 29, 2019 Allergan plc (NYSE: AGN) reported its full-year and fourth quarter 2018 financial results including full-year 2018 GAAP net revenues of $15.79 billion, a 1.0 percent decrease from 2017 (Press release, Allergan, JAN 29, 2019, View Source [SID1234532942]). Fourth quarter 2018 GAAP net revenues were $4.08 billion, a 5.7 percent decrease from the prior year quarter.

Executive Commentary
"Allergan posted another quarter of strong results to close out 2018, underscoring our focus on execution, financial discipline and the strength of our core business which grew 8.3 percent. Our anchor brands BOTOX Cosmetic, BOTOX Therapeutic, VRAYLAR, JUVÉDERM, Lo LOESTRIN, CoolSculpting and LINZESS added nearly $1 billion in new revenue to our core business in 2018," said Brent Saunders, Chairman and CEO of Allergan. "I’m also proud of the significant advances we have made in our R&D pipeline with positive clinical results reported from six late-stage development programs. We look to build on that progress in 2019."

"Taken together, these accomplishments and our talented colleagues give me confidence in our ability to continue producing solid results in 2019 and beyond, while also delivering innovation that will have an enduring impact on patients, customers and shareholders."

Full-Year 2018 Performance
GAAP operating loss in 2018 was $6.25 billion compared with $5.92 billion in 2017. Non-GAAP operating income, which excludes the impact of impairments, amortization and other items, was $7.56 billion in 2018 compared to $7.65 billion in 2017, impacted by lower revenues as operating margin remained stable. GAAP cash flow from operations for the full year of 2018 totaled $5.64 billion.

Fourth Quarter 2018 Performance
GAAP operating loss in the fourth quarter 2018 was $5.38 billion, including the impact of impairments. Non-GAAP operating income in the fourth quarter of 2018 was $1.92 billion, a decrease of 11.8 percent versus the prior year quarter, impacted by lower operating margin and revenues due to the impact of divestitures, products that lost exclusivity and a decline in RESTASIS. GAAP cash flow from operations for the fourth quarter of 2018 totaled $1.50 billion.

Operating Expenses
Total GAAP Selling, General and Administrative (SG&A) Expense was $1.19 billion for the fourth quarter 2018, a decrease of 5.8 percent from the prior year quarter. Total non-GAAP SG&A expense was $1.14 billion for the fourth quarter 2018 compared with $1.13 billion in the prior year period, including an increase in selling and marketing spending in Medical Aesthetics offset by the impact of previous restructurings. GAAP R&D investment for the fourth quarter of 2018 was $678.1 million, compared to $408.2 million in the fourth quarter of 2017. Non-GAAP R&D investment for the fourth quarter 2018 was $436.1 million compared to $405.7 million in the prior year quarter, due to increased direct project spend to support pipeline advancement.

Amortization, Tax and Capitalization
Amortization expense for the fourth quarter 2018 was $1.57 billion, compared to $1.92 billion in the fourth quarter of 2017. The Company’s GAAP tax rate was 23.2 percent in the fourth quarter 2018. The Company’s non-GAAP adjusted tax rate was 14.3 percent in the fourth quarter 2018. As of December 31, 2018, Allergan had cash and marketable securities of $1.91 billion and outstanding indebtedness of $23.8 billion.

Impairments
In the fourth quarter of 2018, Allergan recorded total pre-tax impairment charges of $5.4 billion. This amount reflects $1.9 billion of other intangible asset impairments, including $1.6 billion for KYBELLA/BELKYRA as sales forecasts have declined. The Company’s intended sale of Anti-Infectives and its increased cost of capital based on market dynamics as well as other commercial factors prompted a review of its General Medicine Reporting Unit goodwill. As a result, the Company wrote off $3.5 billion of total goodwill, including $622 million allocated to Anti-Infectives.

FOURTH QUARTER 2018 BUSINESS SEGMENT RESULTS

U.S. Specialized Therapeutics
U.S. Specialized Therapeutics net revenues were $1.81 billion in the fourth quarter of 2018, a decrease of 3.9 percent versus the prior year quarter. Volume demand growth in BOTOX Therapeutic and Facial Aesthetics, including BOTOX Cosmetic and JUVÉDERM Collection, was offset in part by a decline in RESTASIS due to lower demand and net pricing, as well as the divestiture of the Company’s Medical Dermatology business on September 20, 2018. Segment gross margin for the fourth quarter of 2018 was 92.3 percent. Segment contribution for the fourth quarter 2018 was $1.23 billion.

Medical Aesthetics

Facial Aesthetics
BOTOX Cosmetic net revenues in the fourth quarter of 2018 were $258.1 million, an increase of 13.0 percent from the prior year quarter.
JUVÉDERM Collection (defined as JUVÉDERM, VOLUMA and other fillers) net revenues in the fourth quarter of 2018 were $158.4 million, an increase of 13.5 percent versus the prior year quarter.
Regenerative Medicine
ALLODERM net revenues in the fourth quarter of 2018 were $94.9 million, a decrease of 3.1 percent versus the prior year quarter.
Body Contouring
CoolSculpting net revenues (including both CoolSculpting Systems/Applicators and Consumables) in the fourth quarter of 2018 were $81.3 million, a decrease of 13.9 percent versus the prior year quarter.
Neurosciences & Urology

BOTOX Therapeutic net revenues in the fourth quarter of 2018 were $433.3 million, an increase of 12.8 percent versus the prior year quarter.
Eye Care

RESTASIS net revenues in the fourth quarter of 2018 were $325.0 million, a decrease of 18.8 percent versus the prior year quarter.
ALPHAGAN/COMBIGAN net revenues in the fourth quarter of 2018 were $97.7 million, a decrease of 4.0 percent versus the prior year quarter.
OZURDEX net revenues in the fourth quarter of 2018 were $29.3 million, an increase of 11.0 percent versus the prior year quarter.
U.S. General Medicine
U.S. General Medicine net revenues in the fourth quarter of 2018 were $1.40 billion, a decrease of 8.4 percent versus the prior year quarter, impacted by lower revenues from NAMENDA XR and ESTRACE due to generic competition, offset by growth from VRAYLAR and Lo LOESTRIN. Segment gross margin for the fourth quarter of 2018 was 86.0 percent. Segment contribution for the fourth quarter 2018 was $946.6 million.

Central Nervous System

VRAYLAR net revenues were $150.5 million in the fourth quarter of 2018, an increase of 71.6 percent from the prior year quarter.
VIIBRYD/FETZIMA net revenues in the fourth quarter of 2018 were $95.5 million, an increase of 7.3 percent from the prior year quarter.
NAMENDA net revenues in the fourth quarter of 2018 were $10.7 million compared to $97.8 million in the prior year quarter, impacted by loss of patent exclusivity for NAMENDA XR in February 2018.
Gastrointestinal, Women’s Health & Diversified Brands

LINZESS net revenues in the fourth quarter of 2018 were $205.2 million, an increase of 5.3 percent versus the prior year quarter.
Lo LOESTRIN net revenues in the fourth quarter of 2018 were $143.8 million, an increase of 13.7 percent versus the prior year quarter.
BYSTOLIC/BYVALSON net revenues in the fourth quarter of 2018 were $151.7 million, a decrease of 3.7 percent from the prior year quarter.
International
International net revenues in the fourth quarter of 2018 were $870.2 million, an increase of 1.0 percent versus the prior year quarter excluding foreign exchange impact, driven by growth in Facial Aesthetics and BOTOX Therapeutic. International net revenues were negatively impacted by a recall of textured breast implants in certain international markets as well as reduced OZURDEX sales following a third quarter product recall in certain markets. Segment gross margin for the fourth quarter of 2018 was 83.2 percent, also impacted by the textured breast implant recall. Segment contribution was $452.0 million.

Facial Aesthetics

BOTOX Cosmetic net revenues in the fourth quarter of 2018 were $157.8 million, an increase of 9.2 percent versus the prior year quarter excluding foreign exchange impact.
JUVÉDERM Collection net revenues in the fourth quarter of 2018 were $174.0 million, an increase of 20.4 percent versus the prior year quarter excluding foreign exchange impact.
Eye Care

LUMIGAN/GANFORT net revenues in the fourth quarter of 2018 were $96.9 million, an increase of 2.2 percent versus the prior year quarter excluding foreign exchange impact.
OZURDEX net revenues in the fourth quarter of 2018 were $29.6 million compared to $60.9 million in the prior year quarter.
Botox Therapeutic

BOTOX Therapeutic net revenues in the fourth quarter of 2018 were $96.7 million, an increase of 6.6 percent versus the prior year quarter excluding foreign exchange impact.
NEW SHARE REPURCHASE PROGRAM

Allergan’s Board of Directors has authorized a new $2.0 billion share repurchase program as part of the Company’s capital allocation strategy. Allergan expects to deploy the program over the next 12 months.

Allergan reaffirmed its commitment to maintaining investment grade credit ratings and achieving a net debt to adjusted EBITDA ratio of less than 2.5X by the end of 2020.

These actions reflect the Company’s conviction in its strategy and strong future cash flow position, allowing for periodic return of cash to shareholders through dividends and share buybacks while maintaining investment grade ratings and continuing its strategy to pay down debt.

PIPELINE UPDATE

Allergan R&D continues to advance its pipeline. Key 2018 late stage clinical achievements and anticipated milestones include:

Cariprazine: Allergan anticipates a regulatory decision from the U.S. Food and Drug Administration (FDA) in the first half of 2019 for the Company’s supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine). The FDA accepted for review Allergan’s sNDA seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults. In 2018, Allergan reported positive Phase 3 results in the third of three pivotal trials of cariprazine in bipolar depression.
Ubrogepant: Allergan anticipates filing a New Drug Application (NDA) with the FDA by the first quarter of 2019 for ubrogepant for the acute treatment of migraine. In 2018, Allergan reported positive results from two Phase 3 clinical trials studying the safety and efficacy of ubrogepant, an oral CGRP receptor antagonist, as well as two positive safety studies, including a long-term safety study of ubrogepant for acute migraine.
Atogepant: Allergan announced positive results from a Phase 2b/3 clinical trial evaluating the efficacy, safety, and tolerability of atogepant, an oral CGRP receptor antagonist in development for migraine prevention. A Phase 3 study has been initiated.
Bimatoprost SR: Allergan reported positive topline results from two Phase 3 clinical trials of Bimatoprost SR, a first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Allergan anticipates submitting an NDA to the FDA in the second half of 2019.
Abicipar: Allergan and Molecular Partners announced two positive Phase 3 clinical trials on Abicipar for the treatment of neovascular age-related macular degeneration. The Biologics License Application (BLA) submission for Abicipar is planned for the first half of 2019. Allergan anticipates results from the MAPLE trial using its further optimized formulation in the first half of 2019.
Brimonidine DDS: Allergan reported positive results in Phase 2b clinical trials for Brimonidine DDS for geographic atrophy secondary to age-related macular degeneration. Allergan plans to initiate Phase 3 clinical trials in the second half of 2019.

(1) GAAP represents EPS for ordinary shareholders. GAAP income per share includes the impact of amortization of approximately $5.6 billion. Non-GAAP represents performance net income per share.

(2) GAAP EPS shares do not include dilution of shares when earnings are a net loss. As such, the dilution impact of outstanding equity awards is not included in the forecasted shares.

FOURTH QUARTER AND FULL-YEAR 2018 CONFERENCE CALL AND WEBCAST DETAILS
Allergan will host a conference call and webcast today, Tuesday, January 29, at 8:30 a.m. Eastern Time to discuss its fourth quarter and full-year 2018 results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 8599848. A replay of the conference call will also be available beginning approximately two hours after the call’s conclusion and will remain available through 11:30 p.m. Eastern Time on February 28, 2019. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406 and entering the conference ID 8599848.

To access the webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available on Allergan’s Investor Relations website.

Allergan Contacts:

Investors:

Manisha Narasimhan, PhD

(862) 261-7162

Christine Chiou

(862) 261-7396

Media:

Amy Rose

(862) 289-3072

Actinium Pharmaceuticals to Host Key Opinion Leader Breakfast on Targeted Conditioning for Bone Marrow Transplant and CAR-T on February 7th

On January 29, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company") reported that it will host a key opinion leader (KOL) breakfast on targeted conditioning for bone marrow transplant (BMT) and CAR-T from 8:00 AM to 9:30 AM EST on Thursday, February 7th, in New York City (Press release, Actinium Pharmaceuticals, JAN 29, 2019, View Source [SID1234532940]).

The event will feature a presentation by KOL Sergio Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center, who will discuss the potential of targeted conditioning with ARCs or Antibody Radiation-Conjugates in conjunction with BMT or Bone Marrow Transplant for patients ineligible or underserved by current conditioning regimens. Dr. Giralt’s presentation will highlight an initial safety and feasibility analysis of data from Actinium’s pivotal Iomab-B Phase 3 SIERRA trial, which were presented in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. Dr. Giralt will be available at the conclusion of the event to answer any questions from the audience.

In addition, members of the Actinium management team will discuss how the Company is applying its ARCs for targeted conditioning in patients prior to CAR-T with the goal of eliminating the need for chemotherapy conditioning regimens like Flu/Cy (Fludarabine and Cyclophosphamide). Finally, management will introduce their AWE or Antibody Warhead Enabling technology platform that has enabled combination trials with Venetoclax, a bio-better of J&J’s darzalex, and a research collaboration with Astellas Pharma, Inc.

This event is intended for institutional investors, sell-side analysts, and business development professionals only and they are requested to RSVP Click Here. For those who are unable to attend in person, a live webcast and replay will be accessible via the link Click Here.

About Dr. Sergio Giralt
Dr. Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center; Chair, Myeloma Service; and a board-certified hematologist/oncologist whose clinical practice and research focus on stem cell transplantation for patients with blood disorders. Previously, Dr. Giralt was Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapies at the University of Texas MD Anderson Cancer Center.

Dr. Giralt and his colleagues pioneered the use of reduced-intensity conditioning regimens for older or more debilitated patients with blood cancers, and are currently using and studying T cell depletion techniques to dramatically reduce the risk of graft-versus-host disease, a serious complication of donor stem cell transplantation. Dr. Giralt’s clinical and research activities include stem cell transplantation for patients with blood disorders and improving treatments for older patients who have acute and chronic leukemia. He has published and presented extensively on these topics. Additionally, Dr. Giralt has served as the principal investigator for a number of clinical trials that examine new treatment approaches for multiple myeloma and other blood cancers that aim to reduce symptom burden and improve treatment tolerability.

Dr. Giralt received his medical degree from Universidad Central de Venezuela. He completed his residency at Good Samaritan Hospital and his fellowship at The University of Texas MD Anderson Cancer Center. Dr. Giralt is Professor of Medicine at Weill Cornell Medical College and the Chief Attending Physician of the Adult Bone Marrow Transplant Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York City. In addition, he is the Melvin Berlin Family Chair in Myeloma Research.

Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome

On January 29, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies (Press release, Innate Pharma, JAN 29, 2019, View Source [SID1234532938]). IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, developed for the treatment of T-cell lymphoma.

Fast Track is a process designed to facilitate the development and expedite the regulatory review of investigational drugs to treat serious conditions and fill an unmet medical need.

"We are pleased that the FDA has granted Fast Track designation to IPH4102 as there remains a high need for treatment options with strong efficacy and adequate safety profile to allow for treatment of Sézarysyndrome, the most aggressive form of cutaneous T-cell lymphoma (CTCL)," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "IPH4102 is a key element of our strategy to build a commercial franchise of treatments focused on rare cancers in the field of hemato-oncology. We intend to initiate a global multi-cohort Phase II study (TELLOMAK) in the first half of 2019 to confirm the clinical activity of IPH4102 in Sézary syndrome and evaluate the potential in other subtypes of T-cell lymphomas, including Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL). We look forward to working with the FDA to advance this promising program through clinical development."

Sézary syndrome is the leukemic variant of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies.

Fast track designation is based on preliminary results of the Phase I dose-escalation and expansion study of IPH4102 in advanced CTCL (n=44). As of October 15, 2018, data from the subgroup of 35 SS patients revealed strong clinical activity, demonstrated by an overall response rate (ORR) of 42.9%, median duration of response (DoR) of 13.8 months and median progression-free survival (PFS) of 11.7 months. The ORR appeared to be higher (n=28, 53.6%) in patients with no histologic evidence of large cell transformation (LCT)*. Importantly, clinical activity was associated with a substantial improvement in quality of life as assessed by the SkinDex29 and Pruritus Visual Analog Scale (VAS) scores. IPH4102 displayed a favorable safety profile, consistent with previous observations.

Triumvira Immunologics to Present at CAR-T Congress EU in London, UK

On January 29, 2019 Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, reported that Dr. Paul Lammers, President & CEO, will both present and moderate a round table discussion at the CAR-T Congress EU, to be held in London UK on January 30-31 (Press release, Triumvira Immunologics, JAN 29, 2019, https://triumvira.com/press-releases/triumvira-immunologics-to-present-at-car-t-congress-eu-in-london-uk/ [SID1234532937]). The invitations acknowledge Triumvira’s expertise in the novel engineering of T cells for the potential treatment of hematological malignancies and solid tumors.

The CAR-T Congress EU is a forum focused on discovering, translating, developing, and commercializing CAR-T into viable and accessible therapies. CAR-T cell therapies have shown transformational activity in hematological malignancies. However, despite the tremendous success so far, there are still hurdles to overcome before CAR-T can be effective in mainstream oncology beyond hematological malignancies. The European CAR-T Congress’ mission is to address the opportunities and challenges that presently face the CAR-T field and maximize the potential of this ground-breaking therapy. As Triumvira’s proprietary T cell Antigen Coupler (TAC) technology is biologically distinct from CAR-T and has the potential to be a next-generation solution, Triumvira seeks to address some of the challenging areas for existing therapies in hematological malignancies and expand treatment activity to solid tumors.

Paul Lammers, MD, MSc, President, and Chief Executive Officer will present and lead a round table discussion at CAR-T Congress EU as follows:

Date: Wednesday, January 30, 2019

Time: 14:20 (GMT)

Venue: Millennium Gloucester Hotel, 4-18 Harrington Gardens, Kensington, London, SW7 4LH

Presentation: Triumvira’s TAC-T cell Technology: A Step Forward in Adoptive T Cell Therapy.

Date: Thursday, January 31, 2019

Time: 10:30 (GMT)

Venue: Millennium Gloucester Hotel, 4-18 Harrington Gardens, Kensington, London, SW7 4LH

Moderating Round Table: Critical Challenges Facing CAR-T Therapy: Strengthening CAR-T for Solid Tumors.