Erlotinib Hydrochloride

Sol-Gel to receive $16 million during 2025 Cash runway is expected to extend into the first quarter of 2027; Company expects to have sufficient cash to complete its Phase III clinical trial SGT-610 Phase III clinical trial top-line results are expected in the fourth quarter of 2026; a significant milestone in the clinical trial of recruiting more than 80% of the patients has been achieved Sol-Gel now estimates the U.S. market potential for SGT-610 to be between $400 to $500 million annually SGT-210 Phase 1b trial in Darier patients is ongoing; 50% of the patients have already completed the trial April 17, 2025 -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced it has entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. Under the terms of the agreement, Sol-Gel will receive a total of $16 million in two installments: $10 million in the second quarter of 2025 and $6 million in the fourth quarter of 2025, which is expected to extend the Company’s cash runway into the first quarter of 2027. This agreement was executed following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products. EPSOLAY is a topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea (papulopustular rosacea) in adults. TWYNEO is a fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. Facilitating the amounts received from this agreement with Mayne Pharma, Sol-Gel will concentrate on the clinical and commercial development of its most advanced innovative product, SGT-610, a hedgehog signaling pathway blocker designed to potentially become the first ever preventative treatment of basal cell carcinomas (BCCs) in Gorlin syndrome patients, if approved. Based on recent independent market research commissioned by Sol-Gel, in which the optimal price recommendation has been established, and based on prevalence of Gorlin syndrome in the U.S., Sol-Gel now estimates the U.S. market potential for SGT-610 to be between $400 and $500 million annually. As of December 31, 2024, Sol-Gel had $19.5 million in cash, cash equivalents, and deposits and $4.4 million in marketable securities for a total balance of $23.9 million. As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits and no marketable securities for a total balance of $16.9 million. “We are pleased to enter into this agreement with Mayne Pharma,” said Mori Arkin, Chairman of the Board and CEO of Sol-Gel. “Having concluded this U.S. transaction, we are in advanced stages of establishing the commercial network of Epsolay and Twyneo outside the U.S. Many partnership agreements have already been signed and others are under negotiation. If the forecasts of our partners, who all made upfront payments for the rights in their territories, are accurate, we believe that the value of the global business could far exceed that of the U.S. business alone. “This agreement with Mayne Pharma is expected to significantly enhance our cash position and enable us to bolster our SGT-610 program and bring the Phase-III trial to completion. In addition to the potential of SGT-610 in the U.S., we believe that the worldwide potential of SGT-610 is very significant as Gorlin syndrome is prevalent globally. “Our Phase-III clinical trial is progressing well, with all of our 41 sites open for enrollment and approximately 80% of the planned number of patients enrolled. We confidentially expect to complete recruitment no later than the third quarter of this year and announce top-line results in the fourth quarter of 2026. “With the funding of the clinical trial accomplished and the timeline established, we would like to share with our investors the reasons as to why we are optimistic about the trial’s potential success.” Mr. Arkin further commented, “It is important to note that all the data supporting our optimistic outlook are based on our post-hoc analysis of the results of the Phase-III clinical study of patidegib that was conducted by our predecessor, PellePharm Inc. “This type of analysis is called a ‘post-hoc analysis’, which we cannot assure you that its conclusions will be replicated in our study. With that said, I would like to explain the reasons for our optimism. “The study conducted by PellePharm did not achieve the statistical significance of the primary endpoint. However, with the assistance of three independent statisticians and several clinical experts, all commissioned by Sol-Gel, significant findings were made after studying the data. “Gorlin syndrome patients who lacked the PTCH-1 mutation responded poorly to patidegib. “When we included in our analysis only patients with a confirmed hedgehog mutation and excluded an additional subset of patients, the superiority of patidegib became very significant – P Mr. Arkin further commented, “I am also pleased to share an update on Sol-Gel’s of our vehicle controlled phase 1b clinical trial on SGT-210 (topical erlotinib) in patients with Darier disease, a significant unmet medical need with an estimated market potential of $200 to $300 million. If the trial will demonstrate the clinical efficacy that we expect, we anticipate filing for a Phase 2 IND in Q2 2025. SGT-210 is currently being used in a compassionate use treatment for a pediatric patient suffering from a rare disease, and the repeated requests for supply from the patient’s family indicates to us that the drug was probably helpful for this patient.” TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment. SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. SGT-210 is a topical erlotinib drug candidate that is formulated for the treatment of Darier Disease and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor, a protein present on cell surfaces that plays a key role in promoting cell growth and division. Darier Disease is a rare, genetic keratinization disorder which is classically characterized scaly crusted papules in a seborrheic distribution and in skin folds. Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company’s pipeline includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas. Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel pharmaceuticals, to offer patients better, safe and more accessible medicines. Mayne Pharma is a leader in dermatology and women’s health in the United States and also provides contract development and manufacturing services to clients worldwide. Mayne Pharma has a 40- year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialized in numerous products that continue to be marketed around the world. The content above comes from the network. if any infringement, please contact us to modify.

Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation 1 European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study 1 BEERSE, Belgium I April 07, 2025 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT ® (amivantamab), in combination with LAZCLUZE ® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards. 1 This approval follows the recent presentation of final overall survival (OS) results from the Phase 3 MARIPOSA study  ( NCT04487080 ), at the 2025 European Lung Cancer Congress (ELCC), showing statistically superior OS with intravenous (IV) amivantamab plus lazertinib versus osimertinib monotherapy in the first-line treatment of patients with advanced EGFR ex19del or L858R substitution mutated NSCLC (hazard ratio [HR], 0.75; 95 percent Confidence Interval [CI], 0.61-0.92; P<0.005). 2 “While great strides have been made in the treatment of EGFR-mutated non-small cell lung cancer, a critical need still exists for treatment approaches that are not only effective but also more convenient for patients, while optimising experience in the clinic,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy.* “The approval of subcutaneous amivantamab will have a meaningful impact on clinical practice, offering patients greater convenience and an improved treatment experience, without compromising on the well-established efficacy of intravenous amivantamab.” The EC approval is supported by positive results from the Phase 3 PALOMA-3 study ( NCT05388669 ), which evaluated non-inferiority of pharmacokinetics (PK) in addition to efficacy and safety of SC amivantamab (administered via manual injection) compared to IV amivantamab (the already approved route of administration), both in combination with lazertinib, in patients with EGFR-mutated advanced or metastatic NSCLC after disease progression on osimertinib and platinum-based chemotherapy. 1,3 The study demonstrated that SC amivantamab was non-inferior to IV amivantamab, meeting both co-primary PK endpoints as measured by amivantamab levels in the blood (C trough and area under the serum concentration time curve from Cycle 2 day 1 to 15). 1 At a median follow-up of 7 months, the overall response rate (a secondary endpoint) was 30 percent (95 percent confidence interval [CI], 24–37) in the SC arm and 33 percent (95 percent CI, 26–39) for IV (relative risk, 0.92; 95 percent CI, 0.70–1.23; P =0.001), meeting the non-inferiority criteria. 1 Administration time for SC amivantamab was approximately five minutes, and results showed a five-fold reduction in infusion-related reactions (IRRs) compared to IV administration. 1 These results were featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology . 1,4 “The approval of subcutaneous amivantamab represents a welcome improvement of the treatment experience for both patients living with EGFR-mutated advanced non-small cell lung cancer and the healthcare professionals who support them,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “This advancement presents an important opportunity to reduce the treatment burden, improve quality of life and give patients more time to focus on what truly matters to them.” The rate of IRRs for patients treated with SC amivantamab combined with lazertinib was shown to be approximately five-fold lower than that observed with the IV formulation (13 percent vs 66 percent, respectively). 1 The majority of IRRs were grades 1 and 2, with one patient experiencing a grade 3 IRR in the SC arm. 1 Preventive blood thinning (prophylactic anticoagulation) was used in most patients in the PALOMA-3 study. 1 Patients receiving prophylactic anticoagulation had lower rates of venous thromboembolic events (VTEs) (10 percent) than those who did not receive prophylaxis (21 percent). 1 Furthermore, VTE incidence was numerically lower in the SC arm vs the IV arm (9 percent vs 14 percent) regardless of anticoagulation status. 1 Severe bleeding risk (grade 3 to 4) was low among patients receiving anticoagulants in both the SC (2 percent) and IV (0.6 percent) arms. 1 Otherwise, the overall safety profile of SC amivantamab is consistent with the known profile of IV administration. 1 The most common all-grade adverse events of any cause that occurred for SC amivantamab compared to IV, were paronychia (54 percent vs 51 percent), hypoalbuminaemia (47 percent vs 37 percent) and rash (46 percent vs 43 percent), respectively. 1 “At Johnson & Johnson, we are dedicated to patient-centered innovation in our mission to address the critical unmet needs in lung cancer treatment and care,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “Our ongoing focus on advancing the clinical development programme for amivantamab reflects our confidence in its potential to become a standard of care for EGFR-and MET-driven lung cancer.” #ENDS# About Amivantamab Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system. 5,6,7,8 The European Commission (EC) has approved amivantamab in the following indications: 8 Intravenous amivantamab: Subcutaneous amivantamab: The recommended dose regimen for SC amivantamab for these indications is 1600 mg (2240 mg for body weight ≥80kg) administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards (Q2W). 8 When given in combination with lazertinib, it is recommended to administer SC amivantamab any time after lazertinib when given on the same day. 8 Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE ® drug delivery technology. 1 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics . 8 ▼ In line with EMA regulations for new medicines, amivantamab is subject to additional monitoring. About Lazertinib In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. 9 An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023. 9 In January 2025, the European Commission EC approved a marketing authorisation for lazertinib, in combination with amivantamab, for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations. 10 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using lazertinib, please refer to the Summary of Product Characteristics . 11 ▼ In line with EMA regulations for new medicines, lazertinib is subject to additional monitoring. About PALOMA-3 PALOMA-3 ( NCT05388669 ), which enrolled 418 patients, is a randomised, open-label Phase 3 study evaluating the non-inferiority of pharmacokinetics (PK), efficacy and safety of subcutaneous amivantamab (administered via manual injection) combined with lazertinib compared to IV amivantamab and lazertinib in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and platinum-based chemotherapy. 1 The co-primary PK endpoints of the study were trough concentration (C trough on Cycle [C] 2 Day [D] 1 or C4D1) and C2 area under the curve (AUCD1-D15). 1 Key secondary endpoints were objective response rate (ORR) and progression-free survival (PFS). 1 Overall survival was a predefined exploratory endpoint. 1 Prophylactic anticoagulation was recommended for the first four months of treatment. 1 About Non-Small Cell Lung Cancer In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022. 12 NSCLC accounts for 85 percent of all lung cancer cases. 13 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined. 12 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. 13 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division. 13,14 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients. 15,16,17,18 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations. 19 The five-year survival rate for all patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment. 20,21,22,23,24,25,26 EGFR exon 20 insertion (ex20ins) mutations are the third most prevalent activating EGFR mutation. 27 Patients with EGFR ex20ins mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent. 21 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://innovativemedicine.jnj.com/emea/ . Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies. References 1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology . 2024;42(3):3593-3605. 2 Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line (1L) EGFR-mutant (EGFRm) Advanced NSCLC: Final Overall Survival (OS) from the Phase 3 MARIPOSA Study. 2025 European Lung Cancer Congress. March 26, 2025. 3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). https://clinicaltrials.gov/ct2/show/NCT05388669 . Accessed April 2025. 4 Leighl N, et al. Subcutaneous Amivantamab Plus Lazertinib Vs Intravenous Amivantamab Plus Lazertinib In EGFR-mutated, Advanced Non-small Cell Lung Cancer (NSCLC): PALOMA-3, A Phase 3, Global, Randomized, Controlled Trial. 2024 American Society of Clinical Oncology Annual Meeting. May 31, 2024. 5 Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res 2016;76(13)(suppl 27216193):3942-3953. 6 Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs . 2017;9(1):114-126. 7 Yun J, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov . 2020;10(8):1194-1209. 8 European Medicines Agency. Amivantamab Summary of Product Characteristics. January 2025. Available at: https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf . Accessed: April 2025. 9 Cho, BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR -mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217. 10 Innovativemedicine.jnj.com/EMEA. European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer . Accessed: April 2025 11 European Medicines Agency. Lazcluze. January 2025. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze . Accessed April 2025. 12 Global Cancer Observatory. Cancer Today. Available at: https://gco.iarc.fr/en . Accessed April 2025. 13 Zappa C, et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res . 2016;5(3):288–300. 14 Wee P, Wang Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers. 2017;9(5):52. 15 Pennell NA, et al. A phase II trial pf adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol . 2019;37(7);97-104. 16 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 17 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget . 2016;7(48):78985-78993. 18 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res . 2015;5(9):2892-2911. 19 American Lung Association. EGFR and Lung Cancer. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr . Accessed April 2025. 20 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol 2016 Apr;11(4):556-65. 21 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore. 22 Shao J et al. The number of brain metastases predicts the survival of non-small cell lung cancer patients with EGFRR mutation status. Cancer Rep (Hoboken). 2022;5(9): e1550. 23 Achrol A et al. Brain metastases. Nat Rev Dis Primers . 2019;17(5): 5. 24 Rangachari D et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer . 2015;88(1): 108-111. 25 Nieva J, et al. A real-world (rw) observational study of long-term survival (LTS) and treatment patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC). Ann Oncol . 2023;34, S774. 26 Girard N, Leighl NB, Ohe Y, et al. Mortality among EGFR-mutated advanced NSCLC patients after starting frontline osimertinib treatment: a real-world, US attrition analysis. Presented at: the European Lung Cancer Congress; March 29-April 1, 2023; Copenhagen, Denmark. Poster 19P. 27 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9. SOURCE: Johnson & Johnson