On October 30, 2018 Xynomic Pharma, a clinical stage US oncology drug development company, reported that it has acquired exclusive global rights to develop, manufacture and commercialize BI 882370, a 2nd-generation RAF inhibitor, from Boehringer Ingelheim, a top-20 global pharmaceutical company (Press release, Xynomic Pharmaceuticals, OCT 30, 2017, View Source [SID1234527683]). Under the terms of the agreement Xynomic will pay upfront, milestone and royalty payments up to approximately $502 million.

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BI 882370 is a potent and selective RAF inhibitor uniquely binding to the DFG-out conformation, whereas marketed BRAF inhibitors occupy the DFG-in conformation. BI 882370 inhibited proliferation of BRAFmut melanoma cell lines with 100x higher potency (EC50 1 – 10 nM) than vemurafenib (VEM), a marketed BRAF inhibitor.

In the colorectal cancer (CRC) animal models, BI 882370 was superior to VEM in both the Colo-205V600V/E model and HT-29V600V/E model. BI 882370 in combination with cetuximab induced tumor regressions in the less sensitive HT-29 model.

In melanoma’s G-361V600V/E model, BI 882370 was superior to VEM, marketed BRAF inhibitor dabrafenib (DAB), marketed MEK inhibitor trametinib (TRA) and DAB-TRA combination. In a second melanoma model A375V600E in which tumors developed resistance to VEM, the TRA-BI 882370 combination demonstrated superior efficacy over TRA-DAB combination.

There were no relevant findings in exploratory toxicology studies at exposures delivering efficacy superior to VEM, DAB and TRA.

"BI 882370, with an impressive efficacy and safety profile demonstrated in animal models, is well positioned to become a best-in-class 2nd-generation Pan-RAF inhibitor for the treatment of B-RAF mutant cancers including CRC and melanoma. We are honored to partner with BI, a global leader in oncology, and will move this asset into clinical testing expeditiously," said Y. Mark Xu, Chairman, CEO and President of Xynomic.

RAF inhibitors have attracted resurged and strong interest in oncology. Compared to 1st-generation, BI 882370 may provide an improved therapeutic window, enabling more pronounced and longer-lasting pathway suppression and thus resulting in improved efficacy.

Xynomic’s pipeline also includes Abexinostat, a potentially best-in-class HDAC inhibitor entering global pivotal Ph 3 trials against Non-Hodgkin’s lymphoma and renal cell carcinoma.

On October 30, 2017 X4 Pharmaceuticals, a clinical stage biotechnology company developing a novel CXCR4 inhibitor to improve immune cell trafficking to treat cancer and rare diseases, reported updated results from the Phase 1 part of an ongoing Phase 1/2 study of X4P-001-IO in combination with Inlyta (axitinib) in patients with clear cell renal cell carcinoma (ccRCC) (Press release, X4 Pharmaceuticals, OCT 30, 2017, View Source [SID1234521340]).

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The results in patients with ccRCC who received the combination treatment of X4P-001-IO, a CXCR4 inhibitor, and Inlyta, Pfizer’s VEGFR kinase inhibitor, showed an objective response rate (ORR) of 29%, including 1 patient achieving a confirmed complete response (CR), with an encouraging disease control rate (DCR) of 93%. 31% of patients entering the study had received one prior line of therapy while the majority of patients (69%) had received at least two prior lines of therapy. The data were presented at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 29 in Philadelphia.

"The combination of CXCR4 inhibition and VEGFR inhibition shows promising clinical results in this very difficult to treat population of patients with ccRCC. These results suggest that X4P-001-IO may address some of the limitations and augment the clinical utility of axitinib, which is a clinically meaningful drug in the treatment of patients with advanced metastatic ccRCC," said Michael Atkins, MD, Deputy Director, Georgetown Lombardi Comprehensive Cancer Center, William M. Scholl Professor of Oncology at Georgetown University School of Medicine, and lead investigator of the study. "These results, while early, are very promising with a strong disease control rate and a manageable safety profile."

Results from the 16 patients with advanced ccRCC enrolled in the dose escalation part of the ongoing Phase 1/2 study as of the data cutoff date of October 2, 2017 were presented and highlights of the poster presentation include:

The combination of X4P-001-IO and Inlyta showed one confirmed complete response (CR) and produced a DCR and ORR of 93 percent (13/14) and 29 percent (4/14), respectively, in the evaluable patient population.
The median duration on treatment at the data cutoff was 22.1 weeks and 44 percent of patients had been exposed to study treatment for at least 24 weeks.
X4P-001-IO in combination with Inlyta was considered to be safe and generally well tolerated. The most frequent treatment-related adverse events (AEs) were hypertension, diarrhea, fatigue, nausea, decreased appetite, headache and dry eye. No grade 4 or 5 AEs were observed.
Pharmacodynamic (PD) measurements demonstrated that the 400 mg dose inhibited the intended target chemokine receptor CXCR4.
Based on the study results, a dose of 400 mg X4P-001-IO once daily with 5 mg Inlyta twice daily has been selected for the Phase 2 portion of the ongoing Phase 1/2 study.
"We are encouraged by the results to date in this first cohort of patients, many of whom have been on study for over six months and have seen early signs of clinical efficacy with manageable side effects," said Sudha Parasuraman, MD, Chief Medical Officer of X4. "We look forward to sharing a comprehensive update on the ongoing Phase 2a clinical trial, as well as the path forward for further development, in 2018."

The Phase 2 portion of the study continues to enroll patients to evaluate the clinical efficacy of X4P-001-IO as measured by objective response rate (ORR), duration of response (DOR), and progression free survival (PFS), as well as explore the correlation of biomarkers with efficacy. (View Source)

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule inhibitor of CXCR4 (C-X-C receptor type 4) that regulates the tumor microenvironment thereby enhancing endogenous anti-tumor responses. CXCR4 is a chemokine receptor that modulates immune function and angiogenesis through the trafficking of key immune cells such as T- cells, dendritic cells, and myeloid derived suppressor cells. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment.

About Renal Cell Carcinoma

Kidney cancer is among the ten most common cancers in both men and women with more than 60,000 new diagnoses each year in the United States.1 Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer, and advanced ccRCC accounts for approximately 20% of the patient population. Therapies for advanced ccRCC include immunotherapies, mammalian target of rapamycin (mTOR) kinase inhibitors, and angiogenesis inhibitors, such as vascular endothelial growth factor (VEGF) inhibitors.2 There continue to be unmet medical needs with advanced ccRCC because durable responses remain a serious clinical challenge for patients with advanced disease.

New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period (Press release, Pfizer, OCT 30, 2017, View Source [SID1234521318]). The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients with active CD support the long-term effectiveness of treatment with INFLECTRA.1 The results also show that INFLECTRA was well-tolerated, with a similar safety profile to REMICADE.1 Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare jointly announced the secondary outcomes from the phase III trial of INFLECTRA in CD at the 25th United European Gastroenterology (UEG) Week.

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*INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the United States (U.S.) and under other brand names in some countries. In the EU, INFLECTRA is marketed as INFLECTRA (infliximab CT-P13)
**REMICADE is a U.S. registered trademark of Janssen Biotech, Inc.

"The data announced today show that 24 weeks (six months) after switching from REMICADE to the Infliximab biosimilar CT-P13, patients with Crohn’s disease continue to experience similar efficacy, safety and tolerability compared to staying on REMICADE," said Stephen B Hanauer, M.D., Professor of Medicine-Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, US. "These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with Crohn’s disease, providing healthcare professionals further confidence when stable patients switch to CT-P13 from REMICADE."

"These new data add to the considerable body of evidence, including real-world studies and the NOR-SWITCH trial, for the switching of stable patients to INFLECTRA," said Sam Azoulay, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health. "Today’s announcement further highlights Pfizer’s commitment to biosimilars and provides additional evidence supporting use of INFLECTRA in Crohn’s disease."

The study previously reported its primary endpoint at six weeks, demonstrating non-inferiority of INFLECTRA compared to REMICADE in the treatment of CD.2

More than 50 real-world studies in IBD have been conducted with INFLECTRA, evaluating over 7,500 IBD patients in real-world settings.2,3,4,5,6,7,8,9,10,11,12,13,14 There is an important and growing body of evidence for the switching of stable REMICADE patients to INFLECTRA. Clinical studies supporting this switch include NOR-SWITCH,15 BIO-SWITCH,16 PROSIT-BIO3 and now CT-P13 3.4.1,2,17 For example, the NOR-SWITCH study published earlier this year showed that switching from REMICADE to INFLECTRA was not inferior to continued treatment with REMICADE when measured across all adult indications.15

About the trial

This is a randomized, double-blind, parallel-group, phase III study conducted over 54 weeks in 220 patients with active CD to compare overall safety and efficacy between INFLECTRA and REMICADE as determined by the Crohn’s Disease Activity Index (CDAI)-70 response rates†.1 The primary endpoint of the 54 week study was collected at week 6 to demonstrate that INFLECTRA is non-inferior to REMICADE in the treatment of CD.2 From Week 30, patients on REMICADE were randomized to either continue on the same treatment or switch to INFLECTRA while patients on INFLECTRA were randomized to either continue on the same treatment or switch to REMICADE.1 Final study results were collected at 54-weeks.1

The pre-specified secondary endpoints reported today include CDAI-70 response rates after week 6, clinical remission,[1] Short Inflammatory Bowel Disease Questionnaire (SIBDQ)[2] results, and safety endpoints including adverse events and immunogenicity. While not powered to draw definitive conclusions, these new data add to the body of evidence supporting use of INFLECTRA in the Crohn’s Disease indication, including switch to INFLECTRA from REMICADE.1 Comparable efficacy, as measured by CDAI-70 response and clinical remission after week 6 was observed, and these response rates were maintained and observed to be similar in all study arms at week 54.1 One-year data including adverse drug reactions, serious adverse events and infections were observed to be similar among all treatment groups.1 There were no clinically meaningful differences in immunogenicity results throughout the study period among treatment groups up to week 54.1

† CDAI: Crohn’s Disease Activity Index, a recognised measure for the evaluation of disease activity. A response to treatment is measured as a decrease of 70 points or greater (CDAI-70).
[1] Clinical remission: decrease in CDAI >150 points
[2] Short Inflammatory Bowel Disease Questionnaire, a health-related quality of life tool measuring physical, social, and emotional status, and has been predominantly used in trials for Crohn’s disease.

ABOUT INFLECTRA: IMPORTANT SAFETY INFORMATION AND INDICATIONS FROM THE U.S. PRESCRIBING INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. INFLECTRA (infliximab-dyyb) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with INFLECTRA.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including INFLECTRA, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take INFLECTRA?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start INFLECTRA.
Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, diabetes, or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take INFLECTRA.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).
Also tell your doctor if you:

Use the medicines Kineret (anakinra), Orencia (abatacept), or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as INFLECTRA.
Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using INFLECTRA during your pregnancy. Tell your baby’s doctor about your INFLECTRA use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and children taking INFLECTRA should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking INFLECTRA.
What should I watch for and talk to my doctor about before or while taking INFLECTRA?

The following serious (sometimes fatal) side effects have been reported in people taking INFLECTRA.

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red, or painful skin or any open sores. INFLECTRA can make you more likely to get an infection or make any infection that you have worse.
Lymphoma or any other cancers in adults and children.
Skin cancer—any changes in or growths on your skin.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash, and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn’t go away, bruising, bleeding, or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision, or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.
The more common side effects with infliximab products are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing, and stomach pain.

INFLECTRA is a prescription medication used to treat:

Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Paediatric Crohn’s Disease

Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies
Ulcerative Colitis

Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven’t responded well to other therapies
Rheumatoid Arthritis

Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate
Ankylosing Spondylitis

Can reduce signs and symptoms in patients with active ankylosing spondylitis
Psoriatic Arthritis

Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis
Plaque Psoriasis

Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if INFLECTRA is appropriate considering other available therapies
Please see full Prescribing Information for INFLECTRA (infliximab-dyyb).

On October 30, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported updated data from the fifth dose cohort of OX1222, a phase 1b dose-ranging study of OXi4503 in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) (Press release, Mateon Therapeutics, OCT 30, 2017, View Source [SID1234521300]).

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Mateon previously reported that two of four patients in this cohort of the study had morphological complete remissions following one cycle of treatment with OXi4503. A morphological complete remission occurs when an AML patient has fewer than 5% AML blasts in the bone marrow count following treatment and has no significant hematologic abnormalities or other evidence of disease.

One of the patients showing disease remission discontinued the study due to an unrelated adverse event. The other patient continued to receive treatment with an additional two cycles of OXi4503 and remains in complete remission with a cytogenetic complete response. A cytogenetic complete response occurs when testing shows eradication of chromosomal abnormalities following treatment.

"We continue to see encouraging signs of safety and efficacy for OXi4503 in Study OX1222, including complete remissions at very low doses and evidence of a dose-response as we progressively increase the dose of OXi4503 in the trial," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "OXi4503 represents a completely new way to treat AML – by both killing tumor cells directly and by destroying their protective environment in the bone marrow. Based on the results seen to date, we are excited about the enormous potential for this compound in relapsed/refractory AML, especially in older patients unable to tolerate the high levels of chemotherapy typically needed to see a response. There is a huge unmet medical need in these patients and they specifically appear to benefit from treatment with OXi4503."

Summarized initial efficacy data generated to date from OX1222 in relapsed/refractory AML or MDS are as follows:

Cohort (Dose) n CR% PR% ORR%
Cohort 1 (3.75 mg/m2) 6 17% 0% 17%
Cohort 2 (4.68 mg/m2) 4 25% 0% 25%
Cohort 3 (6.25 mg/m2) 4 25% 25% 50%
Cohort 4 (7.81 mg/m2) 3 0% 33% 33%
Cohort 5 (9.76 mg/m2) 4 50% 0% 50%
n: number of patients
CR: complete remission
PR: partial remission
ORR: overall response rate (sum of partial and complete)
OXi4503 continues to have a favorable safety profile. The most common adverse events (AEs) of any grade across all cohorts include neutropenia, fever, nausea, anemia and diarrhea. Grade 3 or above AEs which were related to treatment include anemia (32%), decreased platelet count (27%), decreased neutrophil count (23%) and decreased white blood cell count (18%).

Mateon is in the process of expanding the size of future, higher-dose cohorts to 10 patients to increase the utility of the data generated. The company is also continuing discussions to secure a partner or otherwise obtain additional capital prior to initiating treatment in the sixth cohort of Study OX1222.

About Acute Myeloid Leukemia
A devastating form of cancer of the blood and bone marrow, AML is the most common type of acute leukemia in adults and accounts for the greatest number of leukemia deaths in the United States. There is no standard regimen of care for patients who relapse following front-line treatment or have refractory disease. According to the NIH’s National Cancer Institute Surveillance, Epidemiology and End Results (SEER) program, there are an estimated 21,380 new cases of AML and 10,590 deaths expected in 2017 in the United States. AML arises from a clonal hematopoietic stem cell and is characterized by accumulation of malignant myeloblasts in the bone marrow and results in ineffective hematopoiesis. AML often responds initially to front-line treatment of conventional cytotoxic chemotherapy, but it often relapses and long-term disease-free survival is low, posing a significant challenge to treat relapsed and/or refractory disease.

About OXi4503
OXi4503 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of AML. It disrupts tumor vasculature residing within bone marrow while simultaneously targeting malignant myeloid cells. Preclinical data show that OXi4503 disrupts bone marrow endothelial cells which normally protect AML cells from exposure to chemotherapeutic agents. In human xenograft animal models of AML, OXi4503 has demonstrated almost complete elimination of leukemic cells. In other animal models, the combination of OXi4503 and cytarabine has shown a much greater effect against AML than either agent alone.

On October 30, 2017 Boehringer Ingelheim and Sarah Cannon Research Institute reported an expansion of their strategic partnership to bring innovative treatments to cancer patients by developing novel immuno-oncology therapies (Press release, Boehringer Ingelheim, OCT 30, 2017, View Source [SID1234521329]). The new effort combines Boehringer Ingelheim’s oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment to evaluate BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy.

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SMAC mimetics are a new class of targeted, small molecules that trigger tumor cell death and immune system activation that may enhance the activity of immunotherapies in the treatment of cancer. Through this collaboration, Boehringer Ingelheim’s BI 891065 will be studied in a Phase I clinical trial [NCT03166631] (link is external) alone and in combination with BI 754091 (anti-PD-1) in patients with advanced metastatic solid tumors. The first patient has been enrolled in the Phase I study, which aims to include approximately 100 patients. Previously, the partners had announced a joint clinical development program to study Boehringer Ingelheim’s BI 754091 (anti-PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs. More immune-oncology combination studies are planned moving forward.

Mehdi Shahidi, M.D.
“Ground-breaking advances in immuno-oncology are expected to transform cancer treatment paradigms. We are significantly expanding our efforts in this area including a broad research program focusing on the development of rational combinations of novel immuno-oncology approaches,” said Mehdi Shahidi, M.D., Global Medical Head Oncology, Boehringer Ingelheim. “As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development,” added Shahidi.

Preclinical data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the Keystone Symposia Conference on Molecular and Cellular Biology earlier this year, suggest that BI 891065 is a promising combination partner for checkpoint inhibitors and, when used together, may provide a new approach to cancer therapy.

“We look forward to continuing our research to find more effective therapies for patients across tumor types through novel immune therapies and combinations of therapies,” said Howard A. “Skip” Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments in the community for our patients.”

Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization (CRO), Sarah Cannon is providing comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. Expansion of the collaboration with Sarah Cannon, will enable rapid patient enrollment and expand access to Boehringer Ingelheim’s investigational oncology treatments through Sarah Cannon’s extensive network across the U.S. and UK.

About Sarah Cannon Research Institute
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.

Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com (link is external).

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for non-small-cell lung cancer (NSCLC) that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.