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Onco-this-Week: Top Tens of 2018

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In the final edition of 2018, Onco-this-Week covers the most impactful oncology news of the year 2018. We showcase  the top ten newsmakers in most impactful approvals, failures, promising trials, biosimilars, and financial deals along with selected Novel Oncology Drug Approvals from FDA. We wish you a happy and prosperous new year 2019!

This edition of Onco-this-Week is Sponsored by

North America Immigration Law Group & Nano-Tag Biotechnologies

Most Impactful Approvals

  1. Larotrectinib: FDA approves Larotrectinib, the first ever TRK inhibitor, as first treatment with a tumor-agnostic indication for NTRK+ patients

  2. Venetoclax and Glasdegib: FDA grants not one but two approvals in 1L elderly or unfit AML patients in the same week – Venclexta’s accelerated approval based on results from the M14-358 study and the M14-387 study and Glasdegib’s approval on the basis of Ph II BRIGHT 1003 trial

  3. Kymriah® (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel): Kymriah gets EU and FDA approvals in R/R B-ALL and DLBCL patients; and Yescarta in R/R DLBCL and PMBCL patients also making them the costliest therapies ever

  4. Tagraxofusp-erzs: FDA approves tagraxofusp-erzs (SL-401) as first treatment in 1L adult and pediatric BPDCN patients

  5. Olaparib: FDA approves Olaparib as first PARP inhibitor for 1L maintenance in BRCAm advanced ovarian cancer patients based on Ph III SOLO-1 trial results

  6. Brentuximab vedotin: FDA approves CD30-targeting MMAE ADC, Brentuximab vedotin, in 1L PTCL patients based on Ph III ECHELON-2 data as first option to come in decades after chemotherapy as standard of care

  7. Cemiplimab: FDA approves PD-1 inhibitor Cemiplimab as first and only treatment specifically approved for advanced CSCC patients based on data from Ph II EMPOWER-CSCC-1 and the two advanced CSCC expansion cohorts from a Ph I trial

  8. Durvalumab: FDA and EU approves Durvalumab as adjuvant maintenance therapy for unresectable stage III PD-L1+ NSCLC patients based on Ph III PACIFIC trial data, making it the first immunotherapy to demonstrate significant OS benefit

  9. Talazoparib: Talazoparib’s FDA approval in gBRCA+ HER2 neg breast cancer patients (including 44% TNBC patients) based on results from Ph III EMBRACA Study (NCT01945775)

  10. Iobenguane I-131: FDA approves Iobenguane I-131 as the first and only approved therapy for rare NETs (pheochromocytoma or paraganglioma)

 

Most Significant Failures

  1. Ph III JAVELIN Ovarian 100 study: Ph III JAVELIN Ovarian 100 trial of Avelumab didn’t support initial hypothesis of PFS improvement in interim analysis in previously untreated ovarian cancer patients

  2. Ph III TAHOE trial: Ph III TAHOE trial of Rova-T as 2L therapy for advanced SCLC halted due to shorter OS with Rova-T arm compared with the topotecan

  3. Ph III EAGLE trial: No survival benefit seen with Durvalumab + tremelimumab in SCCHN patients progressing following platinums, regardless of PD-L1 tumor status.

  4. Ph III CheckMate-331 trial: Nivolumab failed to improve OS compared with the standard chemotherapy of topotecan or amrubicin in 2L+ SCLC patients

  5. Ph III ARCTIC trial: Durvalumab + Tremelimumab combo fails to meet primary endpoint of PFS and OS improvement in PD-L1 low/neg 3L NSCLC patients

  6. Ph III KEYNOTE-061 study: Pembrolizumab fails to show survival benefit in PD-L1 ≥1 Gastric/GEJ cancers progressing on platinum-fluoropyrimidine treatment

  7. Ph III PRODIGE9 trial: Bevacizumab maintenance after frontline induction therapy reveals no survival benefit (progression-free or overall) in CRC patients

  8. Ph IIb METRIC trial: CellDex discontinues Glembatumumab development after the first-in-class GPNMB inhibitor fails in gpNMB-overexpressing TNBC

  9. Ph III LUME-Meso trial: Nintedanib failed to improve PFS in unresectable, epithelioid malignant pleural mesothelioma patients

  10. Ph III ECHO-301/KEYNOTE-252: Ph III trial with combination of epacadostat and pembrolizumab failed to demonstrate a statistically valid PFS improvement in unresectable/metastatic melanoma patients

 

Most Promising Trials

  1. Ph III IMpassion130 trial: FDA grants priority review to Atezolizumab + Abraxane in 1L PD-L1-positive mTNBC patients based on significant reduction in PFS, risk of disease worsening or death; PDUFA: Mar 2019

  2. Ph IIb STORM trial: FDA grants priority review to Selinexor for penta-refractory multiple myeloma patients refractory to glucocorticoids, at least one PI, at least one IMiD, Daratumumab and their most recent therapy; PDUFA: Apr 2019

  3. Ph III QuANTUM-R trial: FDA grants priority review for FLT3 inhibitor Quizartinib for treatment of patients with R/R FLT3-ITD AML, making it the first FLT3 inhibitor to demonstrate a survival benefit in a randomized Ph III trial; PDUFA: May 25, 2019

  4. Ph III TAGS (TAS-102 Gastric Study) trial: FDA grants priority review to TAS-102 for previously treated gastric/GEJ cancer; PDUFA: Feb 2019

  5. Ph III KEYNOTE-181 trial: Pembrolizumab significantly improved OS in PD-L1+ advanced esophageal or EGJ carcinoma patients in Ph III KEYNOTE-181 trial – becomes the first PD-1 inhibitor to demonstrate a survival benefit for these patients

  6. Ph II STELLAR trial: TTFs + SoC chemotherapy significantly extends mOS by 6.1 months in STELLAR Ph II registration trial in Mesothelioma, pitching it as first indication outside of the brain where TTFs show exemplary performance

  7. Ph I/II LIBRETTO-001 trial: LOXO-292 gets breakthrough therapy designation for the treatment of RET fusion-positive Thyroid Cancer based on 45% ORR in RET-mutated MTC patients

  8. Ph III CheckMate-227 study: Nivolumab + Ipilimumab demonstrated a statistically significant HR of 0.58 (97.5% CI: 0.41 to 0.81; p=0.0002) versus chemotherapy in patients with TMB ≥10 mut/Mb. A descriptive analysis showed a positive trend for OS, which is secondary endpoint

  9. Ph II Tipifarnib registrational trial: Registrational AIM-HN trial of Tipifarnib was initiated in HRAS m+ SCCHN patients after announcement of preliminary results from its Ph II open-label trial where four out of six evaluable HRAS mutant HNSCC achieved a confirmed PR

  10. Ph II STARTRK-2, Ph I STARTRK-1 and Ph I ALKA-372-001 trials: Entrectinib shrank tumours in people with NTRK fusion-positive ten different solid tumours irrespective of tumour type or CNS spread. Entrectinib has been granted Breakthrough Therapy Designation (BTD) by FDA; PRIME designation by the EMA; and Sakigake designation by the Japanese health authorities for the treatment of NTRK fusion-positive tumors

 

Novel Oncology Drug Approvals for 2018

(covering those not already mentioned above)

  1. Calaspargase pegol-mknl (12/20/2018): To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years

  2. Gilteritinib (11/28/2018): To treat patients who have relapsed or refractory acute myeloid leukemia (AML)

  3. Lorlatinib (11/2/2018): To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer

  4. Dacomitinib (9/27/2018): To treat metastatic non-small-cell lung cancer

  5. Duvelisib (9/24/2018): To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma

  6. Moxetumomab pasudotox-tdfk (9/13/2018): To treat hairy cell leukemia

  7. Mogamulizumab-kpkc (8/8/2018): To treat two rare types of non-Hodgkin lymphoma

  8. Ivosidenib (7/20/2018): To treat patients with relapsed or refractory acute myeloid leukemia

  9. Encorafenib (6/27/2018): To treat unresectable or metastatic melanoma

  10. Binimetinib (6/27/2018): To treat unresectable or metastatic melanoma

  11. Apalutamide (2/14/2018): To treat a certain type of prostate cancer using novel clinical trial endpoint

  12. Lutetium Lu 177 dotatate (1/26/2018): To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

 

Biosimilar News

  1. Ogivri (trastuzumab-dkst), Trastuzumab biosimilar: Approved in EU for HER2+ breast or metastatic stomach cancer (gastric or GEJ adenocarcinoma) patients

  2. Bevacizumab-biosimilar Zirabev: Positive CHMP opinion for treatment of mCRC, metastatic breast cancer, unresectable advanced, mNSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix

  3. HERZUMA (trastuzumab-pkrb): FDA approval in HER2 overexpressing adjuvant and metastatic 1L/2L+ breast cancer patients

  4. HERZUMA: Celltrion Receives EU Approval for Trastuzumab Biosimilar for early breast cancer, metastatic breast cancer, and metastatic gastric cancer

  5. Truxima (rituximab-abbs): FDA approval as the first biosimilar to Rituxan for CD20+ B-NHL patients as monotherapy or in combination with chemotherapy

  6. Hyrimoz(TM) (adalimumab-adaz): Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz) for all indications of reference medicine not protected by orphan exclusivity

  7. MVASI: Post FDA approval and positive CHMP opinion, Bevacizumab biosimilar MVASI gets approved in 5 eligible indications

  8. TRAZIMERA: TRASTUZUMAB biosimilar receives EU approval in HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction Adenocarcinoma

  9. ABP 980: ABP 980 (Biosimilar Herceptin®) receives positive CHMP opinion for the treatment of three types of cancer

  10. PF-05280586: Ongoing REFLECTIONS B328-06 trial met its primary endpoint of comparable safety and efficacy for FL patients as per 26-week data

 

Major Financial Deals

  1. Novartis completes acquisition of Endocyte and adds 177Lu-PSMA-617, a potential first-in-class radioligand therapy in Phase III development for mCRPC to expand expertise in radiopharmaceuticals

  2. Cilag GmbH International, an affiliate of Janssen, gets license for anti-CD70 SIMPLE Antibody cusatuzumab (ARGX-110) Rights to PI3Ki ME-401 and EGFRi Lazertinib secured by MEI Pharma and J&J, respectively

  3. AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma; obtains full rights to anti-NKG2A antibody monalizumab

  4. Geron regains the global rights of first-in-class telomerase inhibitor Imetelstat; collaboration with Janssen discontinued

  5. Sierra Oncology acquires Momelotinib, an investigational JAK1/2 and ACVR1 Inhibitor for Myelofibrosis, from Gilead Sciences

  6. Adlai Nortye Announce Global License Agreement for Buparlisib (BKM120) and acquires development and marketing rights of its PGE2 receptor antagonist E7046 from Eisai

  7. GSK to develop and commercialize NY-ESO SPEAR T-cell therapy program

  8. MabVax Therapeutics licenses its antibody development program targeting multiple solid tumor cancers to Boehringer Ingelheim

  9. Celgene acquires Juno Oncology to add CAR-Ts and TCRs to its portfolio

 

About the Author: 

Richa earned her PhD at the National Brain Research Centre, India. For her thesis, she worked on the dreaded Glioblastoma multiforme. That was her first in-depth exposure to academic research in cancer biology. After her PhD, she expanded her research experience by working in the field of immunology at UCLA, USA. After her return to India, Richa switched to a corporate setting but continued her engagement with the cancer field. She is currently loving her work, which affords her the opportunity to continue developing her knowledge in the biomedical field of cancer. Outside of work, she enjoys watching, identifying and photographing birds.

Editor and Blog Design:

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. He is currently an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His current research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Image Sources: Wikipedia and Twitter

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The authors and editors for Onco-this-week declare no financial benefits or remuneration from the sponsors. The sponsorships support the non-profit organization PhD Career Support Group (PhD CSG). The research conducted by authors and editors is a voluntary effort to popularize science for the public on behalf of PhD CSG. The sponsors do not have any influence on the nature or kind of the news/analysis reported in Onco-this-Week. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Club SciWri or PhD CSG. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Club SciWri or PhD CSG. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

 

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The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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