In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Author By. Confirm Ras mutation status in tumor specimens prior to initiating ERBITUX. Common adverse reactions (all grades) occurring in ≥20% of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) receiving ALIMTA in combination with pembrolizumab and platinum chemotherapy (carboplatin or cisplatin) versus ALIMTA with platinum chemotherapy + placebo for initial treatment (KEYNOTE-189), respectively, were nausea (56% vs 52%); fatigue (56% vs 58%); constipation (35% vs 32%); diarrhea (31% vs 21%); decreased appetite (28% vs 30%); rash (25% vs 17%); vomiting (24% vs 23%); cough (21% vs 28%); dyspnea (21% vs 26%); and pyrexia (20% vs 15%). In MONARCH 3, the median time to onset of the first diarrhea event was 8 days, and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. NSCLC, Medullary Thyroid Cancer, Papillary Thyroid Carcinoma, or Other Advanced Solid Tumors, United States and Canadian Academy of Pathology Annual Meeting, St. Gallen International Breast Cancer Conference, American Association for Cancer Research Annual Meeting. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers. Eli Lilly has 7 approved drugs in its oncology portfolio including Cyramza, Verzenio, Erbitux, Portrazza, Gemzar, and Retevmo. Eli Lilly has a total of 46 R&D projects featuring a small-sized priority R&D pipeline compared to its peers: 6 projects. The incidence of Grade 3 or 4 late radiation toxicities was similar between radiation therapy alone and the ERBITUX with radiation treatment groups. The most common adverse reactions (all grades; incidence ≥25%) seen in patients with K-Ras wild-type, EGFR-expressing  mCRC treated with ERBITUX + best supportive care (BSC) (n=118) versus BSC alone (n=124) (CA225-025) were rash/desquamation (95% vs 21%), fatigue (91% vs 79%), nausea (64% vs 50%), pain-other (59% vs 37%), dry skin (57% vs 15%), constipation (53% vs 38%), dyspnea (49% vs 44%), pruritis (47% vs 11%), neuropathy-sensory (45% vs 38%), diarrhea (42% vs 23%), vomiting (40% vs 26%), headache (38% vs 11%), infection without neutropenia (38% vs 19%), other-dermatology (35% vs 7%), stomatitis (32% vs 10%), nail changes (31% vs 4%), cough (30% vs 19%), insomnia (27% vs 13%) and fever (25% vs 16%). Details on the study design of two confirmatory Phase 3 trials, LIBRETTO-431 and LIBRETTO-531, will additionally be shared. Clinically relevant adverse reactions reported in ≥1% and <10% of CYRAMZA-treated patients in REACH-2 were IRR (9%), hepatic encephalopathy (5%) including 1 fatal event, and hepatorenal syndrome (2%) including 1 fatal event. Please see full U.S. Prescribing Information for CYRAMZA. Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. The addition of ERBITUX resulted in an increase in the incidence of Grade 3 and 4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances compared to radiation and cisplatin alone. Global Aurora-A Kinase Inhibitors Pipeline Insight Report 2021: TransThera Biosciences, Eli Lilly and Co, Takeda Oncology, Wigen Biomedicine, TT-00420. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. The rate of gastrointestinal perforation in REGARD was 0.8% and the rate of IRR was 0.4%. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. ALL RIGHTS RESERVED. Ibuprofen increases exposure (AUC) of pemetrexed. For all FDA-approved indications for ALIMTA, please see full Prescribing Information. The following sites were affected:  salivary glands (65% vs 56%), larynx (52% vs 36%), subcutaneous tissue (49% vs 45%), mucous membrane (48% vs 39%), esophagus (44% vs 35%), skin (42% vs 33%). Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. IMPORTANT SAFETY INFORMATION FOR VERZENIO® (abemaciclib). Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work. Premedicate prior to each CYRAMZA infusion. The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole and ≥2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%). CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Ned Pagliarulo ... An experimental cancer drug being tested by Eli Lilly did not extend survival versus a common chemotherapy regimen in patients with metastatic pancreatic cancer, the latest in a series of clinical setbacks for drugmaker efforts to develop new therapies for the hard-to-treat tumor type. Prior to treatment with ALIMTA, patients must be instructed to initiate supplementation with oral folic acid. CYRAMZA® Lung Cancer Data Highlights Earlier this year, the FDA approved CYRAMZA® (ramucirumab) in combination with erlotinib for the first-line treatment of people with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, based on results from the Phase 3 RELAY study. An increased incidence of severe hypertension occurred in patients receiving CYRAMZA. There are no available data for ERBITUX exposure in pregnant women. Therefore, Retevmo has the potential to adversely affect wound healing. During ESMO, Lilly will present patient-reported outcomes and quality of life findings from both the RET fusion-positive NSCLC and RET-mutant MTC patient cohorts. Permanently discontinue CYRAMZA in patients who experience an ATE. Eli Lilly’s acquisition of Loxo has added the FDA approved asset VITRAKVI and the early- and mid-stage oncology pipeline assets LOXO-305, LOXO-195, and LOXO-292. The safety and effectiveness of Retevmo have been established in pediatric patients aged 12 years and older for medullary thyroid cancer (MTC) who require systemic therapy and for advanced RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of objective response rate (ORR) and duration of response (DoR). The most common adverse reactions (all grades; incidence ≥25%) seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) (BONNER) were acneiform rash (87% vs 10%), radiation dermatitis (86% vs 90%), weight loss (84% vs 72%), asthenia (56% vs 49%), nausea (49% vs 37%), increased alanine transaminase (43% vs 21%), increased aspartate transaminase (38% vs 24%), increased alkaline phosphatase (33% vs 24%), fever (29% vs 13%), emesis (29% vs 23%), pharyngitis (26% vs 19%) and dehydration (25% vs 19%). If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently. not been established. Gastric Cancer CYRAMZA, as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs 6%), and weight decreased (10% vs 2%). Verify pregnancy status in females of reproductive potential prior to initiating ERBITUX. A recommended dosage has not been established for patients with severe renal impairment or end-stage renal disease. The most common adverse reactions (all grades; incidence ≥25%) seen in patients with K-Ras wild-type, EGFR-expressing mCRC treated with a cetuximab product in combination with FOLFIRI (n=317) versus FOLFIRI alone (n=350) (CRYSTAL) were acne-like rash (86% vs 13%), diarrhea (66% vs 60%), neutropenia (49% vs 42%), rash (44% vs 4%), stomatitis (31% vs 19%), anorexia (30% vs 23%), dermatitis acneiform (26% vs <1%) and pyrexia (26% vs 14%). Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the final dose. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed for injection) and platinum as first-line therapy in advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with gemcitabine and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. Grade 3-5 IRR incidence was <1%. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established. For patients with non-squamous histology, the overall incidence of pulmonary hemorrhage was 7% and the incidence of Grade ≥3 pulmonary hemorrhage was 1% for CYRAMZA with docetaxel compared to 6% overall incidence and 1% for Grade ≥3 pulmonary hemorrhage for placebo with docetaxel. Hypertension occurred in 35% of patients, including Grade 3 hypertension in 17% and Grade 4 in one (0.1%) patient. IRR, including severe and life-threatening IRR, occurred in CYRAMZA clinical trials. Increased AST occurred in 51% of patients, including Grade 3 or 4 events in 8% and increased ALT occurred in 45% of patients, including Grade 3 or 4 events in 9%. Use of cetuximab in patients with Ras mutations resulted in no clinical benefit with treatment related toxicity. Abstract LBA5_PR: Abemaciclib in high risk early breast cancer (Stephen R. Johnston) Accepted for Presidential Symposium II September 20 at 19:51-20:03 CEST, Abstract 273O: nextMONARCH: Final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer (Erika P. Hamilton) Accepted as Oral Presentation September 19 at 17:28-17:40 CEST; Session: Breast Cancer, Metastatic 1, Abstract 174P: Genomic testing, biomarkers and treatment patterns in early breast cancer (Michael Method) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 181P: The use of Ki67 testing and scoring in HR+, HER2- early breast cancer (Jacqueline Brown) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 240P: A multinational real-world study on HR+, HER2- early stage breast cancer patients' disease awareness, satisfaction, and involvement in treatment decisions (Alex Rider) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 239P: Impact of clinical characteristics, patients' perception of treatment goals and endocrine therapy history on HRQOL in HR+, HER2- early stage breast cancer patients (Rhys Williams) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1291P: Hypersensitivity reactions (HR) to selpercatinib in RET fusion+ non-small cell lung cancer (NSCLC) patients (pts) following immune checkpoint inhibition (CPI) (Caroline E. McCoach) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1290P: Efficacy and safety with selpercatinib by last prior systemic therapy received in patients (Pts) with RET fusion + non-small cell lung cancer (NSCLC) (Oliver Gautschi) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1292P: Exploratory patient-reported outcomes (PROs) among patients with RET-fusion non-small cell lung cancer (NSCLC) in LIBRETTO-001: A phase I/II trial of selpercatinib (Anna R. Minchom) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1922P: Exploratory patient-reported outcomes among patients with RET-mutant medullary thyroid cancer in LIBRETTO-001: A phase I/II trial of selpercatinib (LOXO-292) (Lori J. Wirth) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1413TiP: LIBRETTO-431: Selpercatinib in treatment (Tx)-naïve patients with RET fusion-positive (RET+) non-small cell lung cancer (NSCLC) (Herbert H. Loong) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1927TiP: LIBRETTO-531: Selpercatinib in patients with treatment (Tx)-naïve RET-mutant medullary thyroid cancer (MTC) (Jorge Hernando) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1294P: RELAY, erlotinib plus ramucirumab or placebo in untreated EGFR-mutated metastatic NSCLC: Outcomes by EGFR mutation type (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1357P: Outcomes of treated patients with EGFR-mutated advanced or metastatic non-small cell lung cancer harboring exon 19 deletions or L858R substitution (Exon 21) mutations: A systematic literature review (Katherine B. Winfree) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1298P: RELAY, ramucirumab plus erlotinib (RAM+ERL) versus placebo plus erlotinib (P+ERL) in untreated EGFR mutated metastatic non-small cell lung cancer (NSCLC): Exposure-response relationship (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1015TiP: Ramucirumab in patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following a non-sorafenib based systemic therapy: An expansion cohort of the phase III REACH-2 study (Richard S. Finn) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 991P: Sintilimab plus IBI305 as first-line treatment for advanced hepatocellular carcinoma (Fan Jia) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1498TiP: A multi-center, randomized, open-label, phase III study of sintilimab + ramucirumab as 1st-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-106) (Ruihua Xu) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1313P: Phase III LEAP-006 safety run-in (Part 1): 1L pembrolizumab (Pembro) + chemotherapy (Chemo) with lenvatinib (Len) for metastatic NSCLC (Makoto Nishio) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 455P: A meta-analysis of efficacy and safety of cetuximab with biweekly vs. weekly dosing (Aparna Parikh) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST.