Merck, Gilead, AZ, BioNTech, Exelixis wins and losses
 

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UPDATED: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors

In a closely watched competition among KRAS inhibitors, Amgen leads the pack with a randomized trial win in lung cancer. Now, the California drugmaker is giving a first look at the detailed data that could set the bar for all others to come, including Mirati Therapeutics, Roche and Novartis.

 
 
 
 

Top Stories

 

Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial

The European Society for Medical Oncology (ESMO) congress could have been a victory lap for Bristol Myers Squibb and Nektar Therapeutics, the moment when a bold bet delivered clinical data to upend the immuno-oncology space. Instead, the partners were left to sift through the wreckage of a failed trial that suggested bempegaldesleukin may make Opdivo less—not more—effective.

 
 
 

Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing

Many Gilead Sciences investors have lost faith in Trodelvy for HR-positive, HER2-negative breast cancer after disappointing tumor progression data. But the drug has now made a surprise comeback with a life extension benefit that came above industry watchers’ expectations, reigniting blockbuster hopes.

 
 
 

Decentralized Digital Health Study: COVID Vaccine Response

Moderna’s COVID-19 antibody response study, made possible by Evidation, reports individuals who received Moderna’s vaccine series had more durable antibody levels than those who received Pfizer.

 
 
 

In crowded kidney cancer space, Exelixis faces uphill battle with modest Cabometyx-BMS triplet showing

Exelixis is hoping a triplet based on Cabometyx and two Bristol Myers Squibb checkpoint inhibitors could have a place in the crowded newly diagnosed kidney cancer space. But data so far suggest an uphill battle ahead.

 
 
 

Seagen's Padcev pulls its weight in combo with Merck's Keytruda

Wednesday at the European Society for Medical Oncology’s annual conference, trial data were presented showing that Seagen's Padcev and Merck's Keytruda perform well together against a form of bladder cancer and that Padcev is a strong contributor to the combo treatment.

 
 
 

Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq

Merck’s Keytruda has long established itself as standard of care in newly diagnosed non-small cell lung cancer. But now Roche aims to carve out a market for Tecentriq by targeting a neglected group of patients.

 
 
 

GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first'

Four months after the latest trial failure for Roche’s tiragolumab, GSK is still pushing ahead with its own anti-TIGIT inhibitor, bullish that plenty of opportunities remain for the next-gen therapy.

 
 
 

Regeneron's plans to take on ovarian cancer with bispecifics boosted with new CD3 data

Regeneron is bullish on its efforts to treat ovarian cancer and new data has provided a boost to its ambitions. A taste of phase 1 findings from one of the company's bispecific antibodies showed a 14.3% objective response rate in a heavily pretreated population.

 
 
 

Bristol Myers, Roche fail in post-surgery kidney cancer. But is it good news for Merck's Keytruda?

Bristol Myers Squibb's and Roche's immunotherapies have both failed to move the needle when used after surgery in early-stage kidney cancer. But the two companies’ setbacks aren’t necessarily a full relief for Merck’s rival drug Keytruda.

 
 
 

Merck's Keytruda-Lenvima flop hands Novartis-BeiGene, Hengrui a brighter liver cancer future

A surprise Keytruda failure in liver cancer spells good news not just for established immunotherapy player Roche but also for potential contenders Jiangsu Hengrui Pharma and a partnership between BeiGene and Novartis.

 
 
 

AstraZeneca's checkpoint inhibitor bispecific may rival Keytruda, but dose change leaves questions

In a race to design the next era of checkpoint inhibitors, AstraZeneca PD-L1 and CTLA-4 bispecific show efficacy rivaling data against Keytruda in first line lung cancer patients. But the dose level eliciting strong durability also came with significant toxicity, spurring a dose reduction.

 
 
 

BioNTech's CAR-T response rate falls in fresh cut of early-phase data

BioNTech has shared a fresh cut of data from a phase 1/2 clinical trial of its CAR-T cell therapy candidate BNT211, revealing a decline in the all-comer response rate but cementing the asset’s credentials as a potential treatment for testicular cancer.

 
 
 

Merck's Keytruda chalks up failure in head and neck cancer. But experts see silver lining

Merck has failed in an attempt to repeat Keytruda’s metastatic head and neck cancer success in locally advanced disease. But experts still see reasons to keep their hopes up for the drug in early stages of this tumor type.

 
 
 

Daiichi dazzles in lung cancer to dial up hopes for next ADC

Another successful antibody-drug conjugate looks set to roll off Daiichi Sankyo’s production line. After teasing early data on the B7-H3-directed candidate one year ago, the Japanese drugmaker has now linked DS-7300 to a 58% response rate in small cell lung cancer and responses in other tumors.

 
 
 

AstraZeneca spinout Dizal planning phase 3 NSCLC study in US before year-end

Fresh off head-turning new phase 2 data, AstraZeneca spinout Dizal says its planning to launch a phase 3 trial of its niche NSCLC treatment in the U.S. before the end of the year. The news comes as the small biotech hopes to keep up with larger pharmas that nabbed approval for the same indication in 2021.

 
 
 

Mirati plays the hits, posting colorectal KRAS data that mirror results reported to fanfare last year

Mirati Therapeutics has taken the lid off updated data on KRAS inhibitor adagrasib in colorectal cancer. Having established itself as the front-runner in the space last year, the biotech has presented a new look at the data that largely reaffirm the earlier findings.

 
 
 

AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer

In a heated PARP inhibitor race with GSK, AstraZeneca and Merck hope some new survival data could consolidate Lynparza’s lead in an ovarian cancer subset. But Merck can’t say the same about a potential prostate cancer expansion.

 
 
 

Eyeing another shot at US market, Hutchmed touts 'practice-changing' colorectal cancer data

Back in 2018, Hutchmed’s fruquintinib became China’s first homemade drug approved locally in a major cancer type. Now, armed with a global trial win, the Chinese biotech is targeting the U.S. colorectal cancer market, with eyes on Bayer and Taiho Pharma.

 
 
 

It's early days for Pfizer's EZH2 inhibitor, but there's a glimpse of hope for some

EZH2 inhibitors have shown their potential—already with one approved therapy and a few in the pipeline—and Pfizer is one of the latest biopharmas to add the tool to its clinical belt. And phase 1 data presented at the European Society of Medical Oncology congress 2022 point to a positive safety profile, with glimpses of benefit for some cancer patients, though not all. 

 
 
 

Multi-cancer blood tests show promise, but questions remain

The advent of blood tests that can detect multiple different cancers at early stages will not only reshape how the disease is diagnosed but will bring about a major shift in the delivery of care.

 
 
 

Relay spotlights expanded FGFR2 inhibitor data it hopes will pave accelerated approval

Relay Therapeutics is walking away from ESMO with strong response data in a new cohort of patients testing the company's bile duct cancer med. The company reported a nearly 90% objective response rate among 17 patients taking the recommended phase 2 dose.

 
 
 

Merck offers 5-year look at Keytruda's landmark lung cancer trials. What's next?

Keytruda’s KEYNOTE-189 trial marked a watershed moment in the history of lung cancer drug development by showing a monster survival benefit. Now, Merck & Co. is giving a five-year look at the data that made the PD-1 inhibitor the standard of care in newly diagnosed patients.