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Today's Rundown

 

    

Thank you to Catalent for sponsoring Fierce Biotech's ESMO 2021 news coverage.

 

Featured Story

With massive tumor progression edge, AstraZeneca-Daiichi's Enhertu shows Roche's Kadcyla who's the better breast cancer drug

Pharma watchers have always suspected that AstraZeneca and Daiichi Sankyo’s Enhertu is a better HER2 therapy than Roche’s Kadcyla. But guessing is all they could do without a head-to-head trial to show just how different the two antibody-drug conjugates are.

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Top Stories

Mirati pulls away from Amgen in colorectal cancer with rival KRAS drug

Mirati Therapeutics has spent 2021 watching Amgen blast past it to win the race to bring a KRAS drug to market in lung cancer. Yet, with Amgen’s Lumakras underwhelming in colorectal cancer, Mirati still has a shot at carving out a niche. The small biotech rocked up to this year’s European Society of Medical Oncology congress with data to make its case. 

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With Mirati hot on its tail, Amgen's KRAS-targeting Lumakras combo heads into late-stage colorectal cancer testing

Amgen is kicking off late-stage testing for its Lumakras and EGFR inhibitor Vectibix combo in patients with KRAS G12C-mutated colorectal cancer after early-stage data showed “encouraging” effectiveness and safety results.  

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Regeneron, Sanofi take another stab at lung cancer with Libtayo-chemo win. Should Merck worry?

In the increasingly crowded market for immunotherapy in newly diagnosed non-small cell lung cancer, Regeneron and Sanofi hope to expand Libtayo into a broader population with a chemo-combo regimen. And now, they've turned up competitive data that could pressure entrenched players Merck & Co. and Bristol Myers Squibb.

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In landmark win, Novartis' Kisqali extends breast cancer survival by one year. Can it challenge Pfizer's Ibrance?

Novartis’ breast cancer drug Kisqali already has two clinical wins under its belt showing a survival benefit over traditional treatment. Now, the company hopes a third, first-of-its-kind victory in newly diagnosed patients could give it a better shot at challenging Pfizer’s market-leading Ibrance. But a shift may not be up to the Swiss pharma.

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Daiichi unveils first early peek at next-gen ADC as analysts see strong data against rivals

Daiichi Sankyo has seen some great successes in the clinic, the deal room and commercially when it comes to antibody-drug conjugates, but it’s not resting on its laurels.

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Merck touts Keytruda's breast cancer survival win as first-to-market Tecentriq leaves the ring

With Roche’s Tecentriq out of the picture, Merck is now detailing key data that prove Keytruda helps triple-negative breast cancer patients lives longer—and shows why it deserves a place in newly diagnosed metastatic disease.

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In newly diagnosed stomach cancer, 2 Opdivo-Yervoy flops show immunotherapy alone might not be the answer

Bristol Myers Squibb boasts a historic go-ahead for Opdivo plus chemotherapy as the first immunotherapy regimen for previously untreated stomach cancer. But the PD-1 inhibitor didn't repeat that success in combination with Yervoy.

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Studies show COVID vaccines effective and safe for cancer patients, but jury still out for one key group

A set of studies released at the European Society for Medical Oncology 2021 virtual congress are painting a clearer picture: The COVID-19 vaccines—particularly Pfizer’s BioNTech-partnered jab—are effective and safe for cancer patients, although researchers say some may need a booster. 

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Merck details Keytruda's 'practice-changing' cervical cancer survival win

Cervical cancer cases are on the decline in the U.S. thanks to increased screening and vaccination with Merck & Co.’s Gardasil. Now, in a first-in-class win, the New Jersey pharma has shown that for patients who unfortunately get cervical cancer, its immunotherapy Keytruda could save lives.

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Novartis links prostate cancer drug to improved pain, quality of life as regulatory filings near

Novartis is building the case for its radioligand therapy. With positive phase 3 primary endpoint data in the bag, Novartis arrived at the European Society of Medical Oncology Congress 2021 armed with evidence of the therapy’s effect on quality of life and pain.

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Facing new Keytruda combos from Merck, BMS touts 5-year kidney cancer data for Opdivo-Yervoy

Bristol Myers Squibb’s combination of Opdivo and Yervoy was the first immuno-oncology regimen to snag an FDA approval for newly diagnosed kidney cancer. While multiple therapies have since entered the market, the New York pharma is now trumpeting five-year data to fend off competition.

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Pfizer, Astellas' latest Xtandi survival data may shore up prostate cancer lead over J&J

Pfizer and Astellas' Xtandi paired with androgen deprivation therapy "significantly" prolonged the lives of men with metastatic hormone-sensitive prostate cancer in a long-awaited analysis of the pair's late-stage ARCHES trial.

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Exelixis lays out promising early Cabometyx combo data in prostate cancer, but key discrepancies persist

Exelixis, looking to dodge another flop with its combo Cabometyx-Tecentriq combo, is touting promising early-stage data in difficult-to-treat prostate cancer patients. However, key discrepancies between the trial investigator and an independent review committee loom.

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Bristol Myers' Opdivo-Yervoy, Pfizer-Merck KGaA's Bavencio hit walls in head and neck cancer

Suffering two separate clinical trial blows, Bristol Myers Squibb and a collaboration between Merck KGaA and Pfizer learned the hard way that head and neck cancer is difficult to treat—even though the experimental therapies may not entirely be to blame.

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Zymeworks lays down marker in fight to unseat Herceptin

Herceptin’s long-lasting dominance of the gastroesophageal cancer market may be under threat. At the European Society of Medical Oncology Congress 2021, Zymeworks presented encouraging early data on its HER2‑targeted bispecific antibody—and a showdown with the incumbent is up next. 

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In unconventional move, Bayer pits genetically driven cancer drug Vitrakvi against Roche's Rozlytrek in adjusted comparison

It’s almost an unspoken rule in the biopharma industry that companies seldom compare two drugs with similar mechanisms of action side by side in the same study. But Bayer decided to go for a comparison of its “tumor agnostic” cancer drug Vitrakvi, though indirectly.

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Merck's Keytruda tames stage 2 melanoma, reducing cancer recurrence in postsurgery use

Stage 3 melanoma was the earliest cancer area to have an FDA-approved immunotherapy to prevent disease from returning after surgery. Now, Merck & Co.’s Keytruda has shown it can do the same in stage 2 skin cancer.

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Resources

Whitepaper: Applications of Digital Twins in Clinical Trials for Alzheimer’s Disease

Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

Whitepaper: The Value of Precision Medicine Informatics Initiatives Research Findings

Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives.

Whitepaper: Challenging Tradition: The Argument for Integrated Commercialization to Improve Operational Agility

Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how.

Whitepaper: High-yield NK cell culture for allogeneic cell therapy applications

Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications.

Whitepaper: Going from Process R&D to Clinical APIs Quickly and Effectively

Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs.

Webinar: Let A Digital Sherpa Uncomplicate The Path for Patients

Topple barriers to getting patients started on therapy. Guide them with mobile.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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