On September 16, 2020 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for the six-month period ended June 30, 2020, and provides an update on progress of its portfolio (Press release, Transgene, SEP 16, 2020, View Source [SID1234565248]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"I would like to thank the teams at Transgene for their remarkable job in advancing all our clinical and preclinical projects in an environment that has been severely disrupted by the Covid-19 pandemic.

During the period we delivered positive Phase 1b/2 results with TG4001, which have given us the confidence to progress the clinical development of this therapeutic vaccine against HPV-induced cancers. We intend to provide more detail on these positive Phase 1b/2 study results in the coming months.

Our oncolytic virus TG6002 showed positive initial data in a Phase 1 trial, indicating that it induces the production of a chemotherapy agent in the tumor. These promising results confirm the safety of TG6002 when given intravenously and are highly supportive of the new generations of oncolytic viruses that we are developing based on our exciting Invir.IO platform.

Patient inclusion continues in line with expectations in the first trials of the individualized immunotherapy TG4050, which has been generated from our myvac platform. The myvac platform and the launch of these trials earlier this year exemplify our technological leadership in individualized immunotherapies. The data which were presented at the AACR (Free AACR Whitepaper) congress in June highlighted the power of NEC’s artificial intelligence and the integration of the first block chain solution into the myvac production process. In parallel, we successfully produced the first clinical batches of TG4050.

The collaboration with AstraZeneca continues with the delivery of new oncolytic viruses.

Finally, by selling part of approximately 40% of the stake in Tasly BioPharmaceuticals for $22.2 million, Transgene has the cash resources to fund its activities until 2022."

Promising initial data for TG4001

The analysis of the efficacy data from the Phase 1b/2 trial combining TG4001 with avelumab in HPV16-positive recurrent and/or metastatic malignancies showed a promising clinical activity in the overall study population (34 evaluable patients).

In addition, Transgene identified a selection criterion corresponding to patients showing particularly encouraging clinical activity. For more than 50% of these patients, the disease had not progressed at 12 weeks, compared to an expected median progression-free survival (PFS) of 8 weeks for this population with current treatment regimens or with immune checkpoint inhibitors in monotherapy. Responses are durable in most of the responder patients. Transgene is currently completing translational analyses. Patient follow-up is still ongoing. Complete data will be presented at an upcoming scientific conference.

Transgene intends to pursue the development of TG4001 and is actively working on the preparation of a confirmatory clinical study.

Advanced technological leadership with the myvac platform

Transgene is developing the therapeutic vaccine TG4050, together with NEC. This individualized cancer vaccine is based on the myvac platform and integrates NEC’s artificial intelligence capabilities.

The first Phase 1 clinical trials assessing TG4050 in patients with ovarian and head and neck cancers started in January 2020 in Europe and in the United States. NEC is financing 50% of these studies.

The Company has set up an in-house production unit dedicated to the manufacturing of the individualized clinical batches of TG4050 needed for each patient. This unit is operational and complies with good manufacturing practice (GMP) norms. The manufacturing process and unit have been validated and the first clinical batches have been produced.

The myvac platform is being actively promoted as it exemplifies Transgene’s technological leadership in individualized immunotherapies.

✓ Data validating the vaccine design principle and underlining the accuracy of the artificial intelligence used to personalize TG4050 were presented at the AACR (Free AACR Whitepaper) congress (June 2020).
✓ Transgene has implemented the first block chain solution dedicated to the traceability of personalized treatment in clinical trials. This cloud-based solution monitors and orchestrates all of the processes related to the design and manufacturing of Transgene’s individualized therapeutic vaccine TG4050.
✓ Other innovative approaches were integrated into the myvac approach and will be detailed in the coming months.

The initial translational data of TG6002 highlight the potential of the Invir.IO platform

Initial data from the Phase 1 trial confirm the good tolerability of TG6002 in humans and demonstrate that this Vaccinia Virus, which is the viral backbone on which the Invir.IO platform is based, can reach the tumor and replicate within these cancer cells when administered intravenously.

BT-001 is the first oncolytic virus from the Invir.IO platform. A first-in-human trial is being prepared; the trial protocol has been filed in France and in Belgium. Promising preclinical results for BT-001 were presented at the AACR (Free AACR Whitepaper) annual congress (June 2020).

The collaboration with AstraZeneca continues with the development of new innovative oncolytic viruses. AstraZeneca can exercise an option to further develop each of these novel drug candidates.

Summary of key ongoing clinical trials

TG4001
+ Bavencio

(avelumab)
Phase 1b/2

Targets: HPV16 E6 and E7 oncoproteins

Advanced HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line

✓ Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓ Very promising results; patient follow-up is ongoing

→ Detailed results will be presented at an upcoming scientific conference

→ Transgene intends to launch a larger, controlled, confirmatory trial

myvac

TG4050

Phase 1

Targets: tumor neoantigens
✓ Data demonstrating the high accuracy of AI-based neoantigen prediction technology used to design TG4050 were presented at AACR (Free AACR Whitepaper)
Ovarian cancer – after surgery and first-line chemotherapy
✓ Trial authorized in the United States and in France
✓ First patient enrolled in January 2020 – inclusions progressing in line with forecast
→ First scientific communication in 2021

TG4050

Phase 1

HPV-negative head and neck cancer – after surgery and adjuvant therapy
✓ Trial authorized in the United Kingdom and in France
✓ First patient enrolled in January 2020 – inclusions progressing in line with forecast
→ First scientific communication in 2021

TG6002
Phase 1/2a

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase 2) – Intravenous (IV) administration

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ First findings confirm that 5-FU is produced in the tumor

→ Dose escalation is ongoing in the Phase 1 part, testing additional dose levels

TG6002
Phase 1/2a

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

✓ Multicenter trial authorized in the United Kingdom

✓ First patient treated in February 2020; enrollment resuming in September 2020 after pausing due to Covid-19

→ First observations in 2021

Invir.IO
BT-001
Phase 1/2

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Collaboration with BioInvent

✓ First clinical trial applications submitted (France and Belgium)

✓ Presentation of very encouraging preclinical results at AACR (Free AACR Whitepaper) 2020

→ Approval from health authorities expected before the end of 2020

Key Financials

The Board of Directors of Transgene met on September 16, 2020 and approved the financial statements for the six-month period ended June 30, 2020. The Statutory Auditors have conducted a limited review of the interim consolidated financial statements.

The half-year financial report is available on Transgene’s website, View Source

Key elements of the income statement

(in thousands of euros)

June 30, 2020

June 30, 2019

Operating revenues

5,731

4,909

Research and development expenses

(13,831)

(14,668)

General and administrative expenses

(3,297)

(3,572)

Other expenses

–

(141)

Operating expenses

(17,128)

(18,381)

Operating income/(loss)

(11,397)

(13,472)

Financial income/(loss)

9,183

(1,870)

Net income/(loss)

(2,214)

(15,342)

Operating revenues amounted to €5.7 million for the first six months of 2020 compared to €4.9 million for the same period in 2019.

In 2019, the Company entered into a collaboration agreement with AstraZeneca with exclusive licensing options to co-develop oncolytic immunotherapies derived from the Invir.IO platform. As a result, in the first half of 2019 Transgene received €8.9 million (US$10 million) in fees for access to its platform. This initial payment is recognized as revenue based on the stage of completion of the related activities. Over the period, the income recognized under this collaboration agreement was €2.2 million (€0.7 million in the first half of 2019). Of this amount €1.8 million reflects recognition of the initial payment for work done during the period and €0.4 million for the achievement of certain preclinical milestones.
The research tax credit amounted to €2.9 million for the first half of 2020, compared to €3.1 million for the first half of 2019.
Research and Development (R&D) expenses amounted to €13.8 million in the first half of 2020 compared to €14.7 million for the same period in 2019. External expenses for clinical projects decreased to €3.0 million from €4.7 million in the first half of 2019. This decrease is mainly due to a reduction in subcontracted clinical batch production expenses in the first half of 2020 compared to the same period in 2019.

General and administrative expenses amounted to €3.3 million for the first half of 2020 compared to €3.6 million for the same period in 2019.

Net interest income amounted to a gain of €9.2 million in the first half of 2020 compared to an expense of €1.9 million for the same period in 2019. This change is mainly due to the increase in the fair value of Tasly Biopharmaceuticals shares: in July 2020, the sale of the shares was carried out at a higher price than the acquisition price in July 2018. This sale price was applied to all the shares held.

As a consequence, the net comprehensive loss amounted to €2.2 million for the first half of 2020 compared to a loss of €15.3 million for the same period in 2019.

As of June 30, 2020, the Company’s cash, cash equivalents and other financial assets amounted to €33.2 million versus €43.3 million as of December 31, 2019.

Transgene’s cash burn amounted to €10.1 million in the first half of 2020, compared with €4.1 million for the same period in 2019.

Transgene intends to reimburse the €10 million bank loan from the European Investment Bank in advance of its June 2021 maturity.

The Company confirms its financial visibility until 2022.

Partial sale of the stake in Tasly BioPharmaceuticals

On August 4, 2020, Transgene announced the receipt of $22.2 million (€19 million) following the sale to a Chinese investment fund of part of its minority stake in Tasly BioPharmaceuticals. This transaction involved the sale of 10.3 million shares of Tasly BioPharmaceuticals (38% of the shares held by Transgene).

Following this share sale, Transgene holds 17.1 million shares in Tasly BioPharmaceuticals, equivalent to 1.58% of the Chinese company’s capital. Transgene’s remaining shareholding in Tasly BioPharmaceuticals is valued at approximately $36.9 million based on the price of the current share sale.

At the end of August 2020, Tasly BioPharmaceuticals filed its IPO documentation with the Science and Technology Innovation Board (STIB) of the Shanghai Stock Exchange.

Succession of the Chairman and Chief Executive Officer planned at the end of 2020

Philippe Archinard, Chairman and Chief Executive Officer of Transgene, has informed the Board of Directors of his intention to leave his position at the end of 2020 to take up new responsibilities within Institut Mérieux. The Board has acknowledged his decision and proposes that his successor be Hedi Ben Brahim, who has been a Board member of Transgene since May 2019. This decision will be approved at the Board meeting scheduled on December 3, 2020. Philippe Archinard will remain a Board Member of Transgene thereafter.

A conference call in English is scheduled today, on September 16th, 2020, at 6:00 p.m. CET.

On September 16, 2020 Kanazawa University reported in Nature Communications the mechanism making some lung-cancer patients resistant to the drug osimertinib (Press release, Kanazawa University, SEP 16, 2020, View Source [SID1234565264]). In addition, they suggest a combined drug treatment resolving osimertinib resistance in the case of cancer cells expressing low amounts of AXL, a protein belonging to the class of receptor tyrosine kinases.

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The effectiveness of cancer treatment is often hampered by cancer cells being heterogeneous. This is the case for EGFR-mutated lung cancer: drugs based on biomolecules of a type known as tyrosine kinase inhibitor (TKI) have been used to treat the disease, but with various levels of efficacy. (EGFR stands for "epidermal growth factor receptor", a protein playing an important role in signaling processes from the extracellular environment to a cell.) Sometimes, tumor cells are simply resistant to the drug. Now, Seiji Yano from Kanazawa University and colleagues have investigated the efficacy of the TKI osimertinib for treating EGFR-mutated lung cancer, and how it relates to the expression in tumor cells of a particular protein called AXL. They found that both AXL-high and -low expressing tumor cells showed tolerance (acquired resistance) to osimertinib, but that the mechanisms involved are different for the two situations. Moreover, the researchers suggest a way to enhance the success of osimertinib treatment for the case of AXL-low expressing tumors.

First, the scientists compared the susceptibility to osimertinib in both AXL-high and -low expressing tumor cells in in vitro experiments. They observed that osimertinib inhibited the viability of the cancer cells in both cases, but that the sensitivity to the drug was higher for AXL-low expressing EGFR-mutated lung cancer cells. They also noticed that a small number of tumor cells survived the procedure — an indication of osimertinib tolerance. These findings were consistent with results from the clinical study of the drug performed earlier on 29 patients with EGFR-mutated non-small cell lung cancer.

Through experiments aiming to understand the mechanism behind osimertinib tolerance, Yano and colleagues discovered that phosphorylation of IGF-1R was increased in AXL-low-expressing tumor cell lines, but not in AXL-high expressing tumors. (IGF-1R stands for ‘insulin-like growth factor 1 receptor’; it is a protein located on the surface of human cells. Phosphorylation is the chemical process of adding a phosphoryl group.) The researchers then found that phosphorylated IGF-1R supported the survival of AXL-low expressing tumors after exposure to osimertinib.

The scientists then tested whether the observed osimertinib resistance could be resolved by administering linsitinib, a substance known to inhibit the phosphorylation of IGF-1R. Encouraged by the positive outcome of the experiment, Yano and colleagues went further and evaluated the combination of osimertinib and linsitinib. Their conclusion was that the transient combination of linsitinib with continuous osimertinib treatment could cure or at least dramatically delay tumor recurrence in AXL-low-expressing EGFR-mutated lung cancer. More investigating needs to be done, though. Quoting the researchers: "… the safety and efficacy of the transient combination of IGF-1R inhibitor and osimertinib should be evaluated in the clinical trials."

Background

Tyrosine kinase inhibitors

A tyrosine kinase inhibitor is a drug inhibiting (that is, preventing or reducing the activity of) a specific tyrosine kinase. A tyrosine kinase is a protein (enzyme) involved in the activation of other proteins by signaling cascades. The activation happens by the addition of a phosphate group to the protein (phosphorylation); it is this step that a tyrosine kinase inhibitor inhibits. Tyrosine kinase inhibitors are used as anticancer drugs. One such drug is osimertinib, used to treat EGFR-mutated lung cancer.

AXL

AXL is a receptor tyrosine kinase — a tyrosine kinase consisting of an extracellular part, a transmembrane part (‘sitting’ within a cell membrane) and an intracellular part. AXL regulates various important cellular processes, including proliferation, survival and motility.

In recent years, it has become clear that AXL is a key facilitator of drug tolerance by cancer cells. Seiji Yano from Kanazawa University and colleagues have found that this is also the case for EGFR-mutated lung cancer. While a high expression of AXL correlates with resistance to osimertinib, such tolerance also occurs in AXL-low-expressing cancer cells. Yano and colleagues have now found that for the latter case, phosphorylation of IGF-1R (insulin-like growth factor 1 receptor) is responsible for the resistance to osimertinib.

Reference

Rong Wang, Tadaaki Yamada, Kenji Kita, Hirokazu Taniguchi, Sachiko Arai, Koji Fukuda, Minoru Terashima, Akihiko Ishimura, Akihiro Nishiyama, Azusa Tanimoto, Shinji Takeuchi, Koshiro Ohtsubo, Kaname Yamashita, Tomoyoshi Yamano, Akihiro Yoshimura, Koichi Takayama, Kyoichi Kaira, Yoshihiko Taniguchi, Shinji Atagi, Hisanori Uehara, Rikinari Hanayama, Isao Matsumoto, Xujun Han, Kunio Matsumoto, Wei Wang, Takeshi Suzuki, and Seiji Yano. Transient IGF-1R inhibition combined with osimertinib eradicates AXL-low expressing EGFR mutated lung cancer, Nature Communications 11, XX (2020).

DOI: 10.1038/s41467-020-18442-4

On September 16, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing proprietary spherical nucleic acid (SNA) technology, reported that it will host a virtual Key Opinion Leader (KOL) event to present preliminary Phase 1b efficacy and safety data for its intratumoral product candidate, cavrotolimod, the company’s SNA-enabled TLR9 agonist being developed for the treatment of solid tumors, in combination with pembrolizumab (Press release, Exicure, SEP 16, 2020, View Source [SID1234565232]). The event will take place today from 10:30 am – 12:00 pm ET.

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The principal investigators of the Phase 1b portion of the trial, Dr. Steven O’Day and Dr. Shailender Bhatia, will be presenting and joining Exicure’s leadership team in discussing the clinical data and trial progress to date.

"We are excited by the durable responses we have seen in anti-PD-1 refractory patients, and look forward to further exploring the efficacy of cavrotolimod in these highly treatment refractory Merkel cell carcinoma and cutaneous squamous cell carcinoma patients," said Dr. Douglas Feltner, Chief Medical Officer of Exicure.

The event will be webcast live today, September 16th at 10:30 am ET through a link on the Events and Presentations section of Exicure’s website. An archived webcast will also be available on Exicure’s website following the event. To RSVP for the event, please use the link here (View Source) or email [email protected].

Description of the Trial

The objectives of the Phase 1b dose-escalation stage of the clinical trial were to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose. Cavrotolimod was dosed weekly for 8 weeks then every three weeks thereafter. Pembrolizumab was added to the treatment regimen starting in week three of the study. The first two weeks of the trial, the period in which only cavrotolimod was dosed, allowed for the assessment of cavrotolimod safety, tolerability, pharmacokinetics and pharmacodynamics alone. Efficacy was assessed every 12 weeks. Twenty patients have been enrolled and dosed in the dose-escalation stage of the trial consisting of: ten (10) melanoma patients, five (5) MCC patients, two (2) CSCC patients, two (2) head and neck squamous cell carcinoma patients, and one (1) leiomyosarcoma patient. At the

time of enrollment, 85% of patients were experiencing progressive disease while on anti-PD-1 antibody therapy.

Highlights from the data

Highlights from the data update include:

–Confirmed ORR 21% (4/19 patients) overall in the Phase 1b dose-escalation stage
–Confirmed ORR 33% (2/6 patients) in the highest dose cohort (32 mg), which was selected as Phase 2 recommended dose
–Overall responses occurred in two patients with advanced MCC and two patients with melanoma
–Three of four responders were progressing on anti-PD-1 therapy at the time of enrollment
–In addition to the four confirmed responses, target tumor shrinkage occurred in one CSCC patient and two melanoma patients. Systemic (abscopal) effects were observed, with regression in noninjected tumors distant from injected lesions.
–The cavrotolimod pharmacodynamic profile corroborated the efficacy data, as increased serum cytokines/chemokines, activated immune cells, and tumor infiltration by immune cells were observed.

The median duration of response has not been reached as all four confirmed responders have not progressed after a median follow-up of 11 months. The longest response to date is 16 months from initial dosing and is ongoing as of the data cut-off date.

Exicure continues to observe that cavrotolimod is well tolerated with 98% of all treatment-emergent adverse events (AEs) assessed as Grade 1 or 2 in severity. No treatment-related serious adverse events were reported to date. The most common adverse events were flu-like symptoms and injection site reactions, which are commonly expected effects from a TLR9 mechanism of action.

Updated guidance

Exicure expects to provide interim ORR results from the MCC and CSCC cohorts of the Phase 2 portion of the clinical trial in the first half of 2021 and final ORR results by year end 2021.

On September 16, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccine against infectious diseases, reported that company’s Chief Executive Officer, Frederic Ors will participate at the Vaccines Panel of the 20th Annual Biotech in Europe Forum held on September 21-24, 2020 (Press release, IMV, SEP 16, 2020, View Source [SID1234565249]).

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The Vaccines Panel will be held on Monday September 21 at 13:05 CET (7.05 am ET) and will be chaired by Thomas Shrader, Managing Director & Healthcare Analyst, BTIG, LLC.

Other panelists include:

Andrei Floroiu, President & CEO, Vaxart Inc.
Andrew Allen, Co-Founder, President & CEO, Gritstone Oncology, Inc.
Johan Van Hoof, Global Therapeutic Area, Head of Infectious Diseases & Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V.
The 20th Annual Biotech in Europe Forum is recognized as the leading international stage for investing and partnering in the biotech and life science industry. This highly transactional event draws together an exciting cross-section of early-stage/pre-IPO, late-stage, and public companies with leading investors, analysts, money managers, and pharma licensing executives. Under current circumstances, including travel restrictions, #Sachs_BEF will be held in a digital format. Please, note that it is a private event—registration on the event website.

On September 16, 2020 OCTIMET Oncology NV, a clinical-stage Belgian life science company with a focus on the development of highly selective, differentiated MET kinase inhibitors, reported the licensing of the Greater China rights for its lead clinical compound OMO-1 and a second preclinical asset exclusively to Shanghai Allist Pharmaceuticals Co., Ltd (Press release, Octimet Oncology, SEP 16, 2020, View Source [SID1234565266]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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OMO-1 is an oral, highly selective small molecule MET kinase inhibitor, that has demonstrated potent single agent and combination activity in a range of preclinical cancer models.

OMO-1 has been evaluated in a monotherapy setting as well as in combination with small molecule EGFR tyrosine kinase inhibitors (TKIs) in Europe, showing a favorable safety profile and early signs of efficacy in MET-selected cancer patients. Allist will drive the clinical development of this compound in China, initially focusing on expanding the combination data with Allist’s third generation EGFR TKI Furmonertinib (AST2818). In China, more than 38% of NSCLC patients harbor activating EGFR mutations, making the region ideal for completing expanded clinical efficacy studies more rapidly whilst addressing a large potential market.

"We are proud to have Shanghai Allist Pharmaceuticals Co., Ltd. as a partner in developing this exciting therapeutic agent," said Shelley Margetson, Chief Executive Officer of OCTIMET. "Development in China is strategically important for OMO-1 and we look forward to seeing the results of the combination studies with Allist’s EGFR TKI compound, thereby making a difference for cancer patients in need of efficacious targeted therapies."

"MET amplification is known to be a key driver of resistance to EGFR TKIs. We are excited to explore further the combination of OMO-1, a differentiated selective MET kinase inhibitor, with our innovative third generation EGFR TKI Furmonertinib and look forward to generating significant efficacy data that will aim to meet clinical unmet need in providing further treatment for seriously ill cancer patients who have few other therapy options," said Ms. Sandy Mou, the CEO from Allist Pharmaceuticals.

About OMO-1

OMO-1 is a small molecule inhibitor of the enzymatic activity of the MET receptor tyrosine kinase (RTK). The MET gene has been shown to be responsible for some hereditary types of cancer. In addition, inappropriate MET activation has been shown in most types of solid tumors, often correlating with poor prognosis (Trusolino et al 2010, Gheradi et al 2012).

About EGFR Tyrosine Kinase Inhibitors

Lung cancer is the leading cause of cancer-related mortality worldwide. Of all lung cancer cases, 80–85% are non-small-cell lung cancers (NSCLC), and the majority of these cases are in advanced or metastatic stage (III or IV) at the time of diagnosis. Among these patients with NSCLC, a substantial number are harboring activating EGFR mutations, ranging from 10% in Europe to 38.4% in Asia. During the past years, EGFR tyrosine kinase inhibitors (TKIs) have been developed and have become standard first-line treatment for patients with EGFR mutation-positive NSCLC. Various trials showed higher response rates and improved progression-free survival (PFS) for first-line treatment with the EGFR TKIs afatinib, erlotinib, and gefitinib compared to platinum-based doublet therapy in patients with activating EGFR-mutated NSCLC.